Medical Device Reports Research Articles

Adverse events associated with Bonebridge and Osia bone conduction implant devices

PurposeActive transcutaneous Bone Conduction Implants (BCIs) are relatively new to the market and may offer improved outcomes while reducing skin-related complications associated with previous models. The purpose of this study is to examine medical device reports (MDRs) submitted to the Food and Drug Administration's (FDA) Manufacturer and User Device Facility Experience (MAUDE) database to identify adverse events with the active, transcutaneous BCIs, Bonebridge and Osia. MethodsA search of the FDA MAUDE database was conducted using product code “PFO” (for Active Implantable Bone Conduction Hearing System), brand names “Bonebridge” and “Osia.” Data was collected on device malfunction, patient injury, inciting events, and subsequent interventions between July 1, 2018 and November 1, 2020. ResultsThe search query yielded 83 reports that met inclusion criteria, 56 regarding Bonebridge and 27 regarding Osia. A total of 91 adverse events were reported, including 45 device malfunctions and 46 patient injuries. Of all adverse events reported for Bonebridge, 15 (26.3%, 15/57) documented patient injuries, while the majority (73.7%, 42/57) documented device malfunctions. Of all adverse events reported for Osia, 3 (8.8%, 3/34) were reported concerning malfunctions, while 31 (91.2%, 31/34) were reported for patient injuries. The most commonly reported adverse events included lack of conduction or hearing (n = 26, 28.6%), infection (n = 14, 15.4%), and intermittent or reduced conduction or hearing (n = 12, 13.2%). From the MAUDE database reported adverse events and the total number of Osia implants given to us from Cochlear over this 28 month period, we estimate patient injuries to occur in roughly 2.1% of patients. ConclusionThere are limitations to the database which make systemic analysis challenging. This study suggests that patients with transcutaneous, active BCIs may be experiencing fewer soft tissue injuries, but similar device malfunctions as those with previous models.

Adverse Events Associated With ClariFix Posterior Nasal Nerve Cryoablation: A MAUDE Database Analysis.

Posterior nasal nerve (PNN) cryoablation is a novel surgical technique used to address chronic rhinitis. The purpose of this study is to review the medical device reports (MDRs) submitted to the Food and Drug Administration's (FDA) Manufacturer and User Device Facility Experience (MAUDE) database to identify adverse events related to the use of ClariFix, a device designed for office-based cryosurgical ablation of the PNN. A total of 12 adverse events associated with ClariFix from January 2017 to August 2020 were identified and analyzed. The most common adverse events associated with ClariFix PNN cryoablation include epistaxis and nasal swelling. Further studies are needed to clarify whether PNN cryoablation is associated with epistaxis in certain populations.

Breast implant-associated anaplastic large-cell lymphoma (BIA-ALCL).

Breast implant-associated anaplastic large-cell lymphoma (BIA-ALCL) is a rare T-cell non-Hodgkin lymphoma characterized as CD30 positive and anaplastic lymphoma kinase (ALK) negative. In 2016, the World Health Organization declared BIA-ALCL as a new disease entity. The first case of BIA-ALCL was reported in 1997, and as of July 2019, the United States Food and Drug Administration had cited a total of 573 United States and global medical device reports of BIA-ALCL, including 33 deaths. In all clinical case reports, except for those with unknown clinical history, the patient had received at least one textured surface breast implant. Although the etiology is not yet clear, chronic inflammation has been proposed as a potential precursor to tumorigenesis. The most common presentation of BIA-ALCL is peri-implant fluid collection following aesthetic or reconstructive implantation with textured surface breast implants. It can be accompanied by breast swelling, asymmetry, pain, skin lesions, lymphadenopathy, and B-type symptoms. Most cases are detected on average 7 to 10 years after implantation. Diagnostic specimens can be obtained with fine-needle aspiration or biopsy. BIA-ALCL is CD30 positive, epithelial membrane antigen positive, and ALK negative. It can be cured with complete surgical excision at the T1–T3 stage.

Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL): A Review and the Caribbean Perspective

ABSTRACT Objectives Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL) is a rare CD-30 positive, Anaplastic Lymphoma Kinase Negative Non-Hodgkins lymphoma. The current estimated incidence is one to three cases per million implanted women. However, this is likely to rise with the increasing popularity of breast augmentation. This article contains a brief literature review and describes the Caribbean response to BIAALCL. Methods A literature search was done on the PUBMED Database. Keywords included ‘breast implant-associated anaplastic large cell lymphoma’, ‘brentuximab vedotin’, ‘breast implant’, ‘texturized implants’. The Caribbean Association of Plastic and Reconstructive Surgeons (CAPRS) formulated a regional response to BIA-ALCL during their meeting in August 2019. Results The Food and Drug Administration (FDA) has received 573 unique medical device reports of BIA-ALCL worldwide. The time from implantation to diagnosis, ranges from 7.5 to 10 years and the median age at diagnosis ranges from 47 to 58 years. The pathophysiology of BIA-ALCL is likely multifactorial and involves chronic inflammation in response to textured implants and chronic biofilm, in a genetically susceptible person. Early presentation has a good prognosis with treatment (5-year survival rate of 70-90%). Conclusion Recommendations included development of a regional breast implant registry, which will facilitate study on implant use and its complications. They also concluded that texturized devices should be avoided and utilization of smooth alternatives or autologous reconstruction be performed. Additionally, if requested by asymptomatic women, explant of textured implants and total capsulectomy is not unreasonable. However, these patients must be appropriately counselled.

Enlightenment on Carrying out Reporting Responsibility of Manufactures in China from Reviewing Medical Device Reporting Practice in US

By introducing the Medical Device Reporting (MDR) system and related inspection practice of the US, this paper puts forward some suggestions on implementing reporting responsibility of manufactures in China. The MDR system and the related inspection system in the US were systematically analyzed. The US had established a sound system for discovering and reporting MDR, and a mechanism for inspecting the implementing of manufactures, forming an effective post-market surveillance system. By learning from the experience of the US, we can carry out the post-market surveillance of medical devices adverse events in China from the aspects of implementing the existing system, strengthening the reporting ability and perfecting the inspection mechanism.

Characterization of Device-Related Malfunction, Injury, and Death Associated with Using Elastomeric Pumps for Delivery of Local Anesthetics in the US Food and Drug Administration MAUDE Database.

PurposeTo characterize medical device reports about elastomeric pumps delivering local anesthesia made to the US Food and Drug Administration Manufacturer and User Facility Device Experience (MAUDE) database.Patients and MethodsWe conducted a retrospective review of medical device reports submitted to MAUDE from January 2010 to July 2018. A systematic, computerized algorithm was used to identify records pertaining to elastomeric pumps using local anesthesia. Included records indicated the use of local anesthesia or were determined to involve the use of local anesthetics (if they did not contain specific information on drug use). Reports were analyzed within the MAUDE event type categories of malfunction, injury, death, other, and missing. Possible cases of liver injury or surgical site infection were also identified. Manual review of narratives provided in MAUDE was performed by 2 reviewers to identify possible or probable cases of local anesthetic system toxicity (LAST).ResultsFrom a pool of 384,285 reports about elastomeric pumps from the MAUDE database, 4093 met inclusion criteria for involving elastomeric pumps to deliver local anesthetics, with the peak number of reports occurring in 2014. Of these identified reports, 3624 (88.5%) were categorized as malfunctions, 292 (7.1%) as injuries, and 8 (0.2%) as involving death. We identified 13 cases (0.3%) of possible liver injury and 51 cases (1.2%) of possible surgical site infection; 139 reports (3.4%) were determined to be probably (n=53) or possibly (n=86) associated with LAST.ConclusionMalfunction of elastomeric pumps delivering local anesthetics leaves patients vulnerable to injury or death. Our study indicates that reports of malfunction, injury, and death have been reported to the MAUDE database. These reports likely reflect an underrepresentation of cases in the real-world population, emphasizing the need for more comprehensive medical device reporting.

PMD20 Cystoscopy Device-Associated Adverse Events - a Thematization Analysis of Medical Device Reports the Last Decade

PMD20 Cystoscopy Device-Associated Adverse Events - a Thematization Analysis of Medical Device Reports the Last Decade

Duodenoscope Medical Device Reports Associated with Patient Infection, Patient Exposure, or Device Contamination

Background: Each year, the FDA receives more than a million reports of suspected device-associated deaths, serious injuries, and malfunctions. Medical device reports (MDRs) are submitted to the FDA by mandatory reporters (manufacturers, importers, and device user facilities) and voluntary reporters such as healthcare professionals, patients, and consumers. The FDA uses MDRs to monitor device performance, including monitoring reports of infection or device contamination to detect potential device-related safety issues and to share this information in public communications. In this analysis, the FDA presents MDRs for duodenoscopes, which are a type of flexible endoscope that have been associated with infections in patients. Methods: For this analysis, we searched the MDR database for duodenoscope reports submitted between January 2015 and July 1, 2019. MDRs were classified into clinical risk categories based on the MDR’s text narratives as patient infection (indicated the presence of infection in patients potentially transmitted by the device), patient exposure (indicated a contaminated device has been used in a patient, but the MDR lacks clear mention of patient infection), or device contamination (indicated that the device was contaminated, but no mention of device use in patients or patient infection). Results: Overall, 1,115 duodenoscope reports related to a patient infection, patient exposure, or device contamination for devices marketed inside and outside the United States were received from January 2015 to mid-2019. Among them, 79 MDRs were received for deaths in patient infection, patient exposure, or device contamination reports. The number of reported infections decreased from 247 MDRs in 2015 to 55 MDRs in the first half of 2019. Furthermore, the number of reported deaths decreased from 25 MDRs in 2015 to 2 MDRs reported in the first half of 2019. Conclusions: The MDR data indicate a decrease in the number of reported infections. The decrease in infections suggests that efforts to reduce the risk of infection from duodenoscopes have yielded improvements; however, additional improvements are necessary to further decrease the risk of infection.Funding: NoneDisclosures: None

Vaginal energy-based devices: characterization of adverse events based on the last decade of MAUDE safety reports.

Energy-based devices have gained momentum as minimally invasive procedures to treat both medical and cosmetic pelvic floor disorders including genitourinary syndrome of menopause, vaginal laxity, stress urinary incontinence, dyspareunia, and vulvar disorders such as lichen diseases and vestibulitis. However, the FDA recently issued a statement cautioning patients and providers that the safety and efficacy of energy-based devices for the treatment of vaginal symptoms has not been well established. Additionally, the FDA sent letters to the manufactures of energy-based devices with notifications that they could be violating the marketing standards of the FDA. The existing data on side effects is insufficient and limited to observational studies. We sought to characterize the safety events of vaginal energy-based devices by analysis of surveillance data from the FDA Manufacturer and User Facility Device Experience (MAUDE) database and specifically look at those events that occurred prior to the July 30, 2018 warning. The MAUDE database was queried between September 30, 2013 and October 31, 2019 for all vaginal energy-based devices. The incidence of safety events was reported for these devices and the most common complaints were described and characterized. Event reporting was analyzed before and after July 30, 2018. Forty-two unique and relevant medical device reports (MDRs) were retrieved. The Mona Lisa Touch had the highest number of MDRs (40.5%) followed by ThermiVa (16.7%) and Viveve (14.2%). Each medical device report was associated with a single patient experience and within the 42 medical device reports, there were 85 complaints. A majority of the MDR complaints (52.9%) were also indications for energy-based devices procedures, which include vaginal pain, dyspareunia, lichen sclerosis, and urinary frequency. Two-thirds of the complaints (68.2%) were related to pain, but serious adverse events such as third-degree burns (3.5%) were rare. Most of the reportable events occurred before July 30, 2018 (83.3%), but most were reported after July 30, 2018 (78.6%). MAUDE-reported data suggests that the majority of patient complaints after vaginal energy-based device treatment include vaginal pain, bladder pain, and urinary symptoms. This study suggests that the majority of complaints are not severe, and some may be related to progression of the disease. The few severe adverse events reported in the MAUDE database may have contributed to the FDA warning regarding energy-based devices. Recall bias after the FDA warning, as well as the potential for litigation, may have prompted an increase in adverse event reporting after July 30, 2018.

Assessment of Data Sources That Support US Food and Drug Administration Medical Devices Safety Communications

Medical Device Safety Communications (MDSCs) are used by the US Food and Drug Administration (FDA) to convey important new safety information to patients and health care professionals. The sources of initial safety signals that trigger MDSCs have not been described previously. To assess the sources of initial safety signals that trigger publication of MDSCs and the potential associations among MDSC data source, type of safety issue, and subsequent FDA action. In this cross-sectional study, all MDSCs published on the FDA website between January 1, 2011, and December 31, 2019, were assessed. The MDSC characteristics, sources of initiating safety signals, regulatory approval or clearance pathways of the related medical devices, and subsequent FDA actions were collected from the FDA website. The main outcome was the distribution of sources of initial safety signals that led to publication of MDSCs. Secondary aims included exploration of potential associations among safety signal sources (direct reporting vs other), type of safety issue (death vs other), and FDA action (withdrawal vs other). A total of 93 MDSCs were evaluated. Median time from device approval to MDSC posting was 10 years (interquartile range, 6-16 years). The most common data sources that triggered MDSCs were direct reports to the FDA through the Medical Device Reporting (MDR) program (44 of 93 [47%]) followed by regulator-initiated assessments (32 [34%]). Common safety issues included patient injury (25 [27%]), potential wrong diagnoses (19 [20%]), and death (18 [19%]). Frequent FDA action after MDSC posting included recommendation for increased vigilance and caution (47 [51%]), complete device withdrawal (12 [13%]), and warnings of specific lots or clinics (12 [13%]). There was a statistically significant correlation between direct reports of adverse events to the FDA through the MDR program and risk of death as a safety issue (14 of 44 [32%] for direct reporting vs 4 of 49 [8%] for any other data sources, P = .007). In this cross-sectional study, the most common source of initial safety signals that triggered MDSCs was direct reports of real-world adverse events to the FDA through the MDR program. The delayed detection of postmarketing adverse events highlights the importance of proactive identification of emerging device-related safety issues.

A cross-sectional analysis of 1347 complications for cervical disc replacements from medical device reports maintained by the United States Food and Drug Administration

Cervical disc replacement (CDR) has increased in popularity over the past decade based on published outcomes from FDA IDE studies with narrowly defined inclusion and exclusion criteria. A low rate of complications was noted in these studies. The broader complication profile for CDR in widespread clinical practice has yet to be described. To outline the complications reported to the FDA regarding commonly used CDR products STUDY DESIGN/SETTING: Retrospective database review PATIENT SAMPLE: Nationwide database of reported complications related to CDR products from patients across the country OUTCOME MEASURES: Complications related to CDR METHODS: We queried the MAUDE database and Alternative Summary Reporting (ASR) data files submitted between January 2005 to March 2020. The complications listed for seven FDA-approved CDR implants were analyzed. The entries in the databases were cataloged for complication type, date of entry, source of report, and whether the investigation was "complete". Reports that had too little information to extract relevant data were excluded. There were 1,517 entries identified in the MAUDE database. After removal of duplicate entries and entries without sufficient information, there were 1,347 entries analyzed. The top five complications were (1) migration of implant (338 entries, 25.2%) (2) insertion problem/failure (312 entries, 23.3%) (3) neck pain (203 entries, 15.2%) (4) heterotopic ossification (108 entries, 8.1%) and (5) radiculopathy (90 entries, 8.1%). The number of analyzed implant-related MAUDE entries and most common implant-related complication for each implant was 209 entries for insertion problem/failure for Mobi-C; 158 entries for migration of implant for ProDisc-C; 154 entries for insertion problem/failure for Bryan cervical disc; 130 entries for migration of implant for Prestige cervical disc; 49 entries for migration of implant for PCM cervical disc; 12 entries for migration of implant for M6 and 10 entries for migration of implant for Secure-C. Only 263 entries (19.5%) were deemed "complete". Most entries were from the manufacturer/company representative/distributor (923 entries, 70%). There were no entries related to cervical disc replacement devices within the ASR data. The MAUDE database highlights complications related to CDR implants that may not be emphasized in currently published studies. It is important to understand this broad complication profile for CDR to ensure safe utilization of this new technology.

An Analysis of FDA Adverse Event Reporting Data for Trends in Medical Device Use Error

Humans can contribute to error at all stages of the medical device product life-cycle. Use error associated with medical devices can result in catastrophic consequences for end users and inefficient use of healthcare system resources. Industry-wide statistics about medical device use error has the potential to aid in identifying opportunities for human factors intervention, however publicly available statistics are sparse. The Food and Drug Administration (FDA) requires medical device manufactures, importers, and device user facilities to track and report adverse events for post-market surveillance through medical device reports (MDRs). This data is available in an online database: Manufacturer and User Facility Experience (MAUDE). This study provides a comprehensive evaluation of use error adverse events in MAUDE (2010-2018) based on device class, device operator, and event outcome, to address the lack of industry-wide statistics on medical device use error. Results indicate that use error is significantly represented in adverse event reporting, constituting 28.1% of reports labeled with device problem codes. Events associated with patient device operators were predominately associated with diabetes-related medical devices, while provider operators were associated with a wider array of devices. Additionally, it was found that most use error reports were attributed to issues with device output; using the device in accordance with manufacturer expectations; and physically activating, positioning, or separating device components. This work demonstrates the viability of using MAUDE to attain industry wide statistics on medical device use error for later integration in industry-wide or device-specific risk mitigation strategies.

Roundtable Discussion: The Challenge of Developing Effective Sterilization and Reprocessing Instructions for Use.

Roundtable Discussion: The Challenge of Developing Effective Sterilization and Reprocessing Instructions for Use.

Evaluating medical device adverse event signals using a likelihood ratio test method

ABSTRACT Signal detection methods have been used extensively in post-market surveillance to identify elevated risks of adverse events. However, these statistical methods have not been widely used in detecting AE signals for medical devices. In this paper, we focused on the use of a likelihood ratio test (LRT)-based method in identifying adverse event (AE) signals associated with left ventricular assist devices (LVADs) using Medical Device Reporting (MDR) data. Among 110,927 adverse event entries identified in MDR data for LVADs, the LRT method detected 18 AE signals which included seven bleeding-related AEs such as hemolysis, thrombosis, hematuria, thrombus, blood loss, and hemorrhage. The LRT method was also applied to longitudinal data from 2007 to 2019 where a monotone alpha-spending function was used to ensure the control of type I error at each look and overall for trend analysis. Furthermore, the LRT method was compared to proportional reporting ratios (PRRs), Bayesian confidence propagation neural network (BCPNN), and simplified Bayes methods and found to be the most conservative method when examining the total number of detected signals, given its ability to control type-I error and the false discovery rate.

Adverse events associated with the Inspire implantable hypoglossal nerve stimulator: A MAUDE database review.

Implantable hypoglossal nerve stimulation (HNS) has been found to be a safe and effective therapy for patients with obstructive sleep apnea, and patient adherence to treatment has been found to be as high as 86% after 12months of therapy. The purpose of this study is to review the medical device reports (MDRs) submitted to the Food and Drug Administration's (FDA) Manufacturer and User Device Facility Experience (MAUDE) database to identify adverse events related to HNS therapy that could hinder compliance. A search of the FDA MAUDE database was conducted using the product code "MNQ" for "Inspire stimulator for sleep apnea." Reports of adverse events associated with Inspire for sleep apnea from January 2000 to May 2020 were included for analysis. From these included reports, event variables were collected, including event setting, adverse event to patient, iatrogenic injury, device malfunction, interventions, and root causes. Results were compiled and reviewed. The search query yielded 180 reports that met inclusion criteria, containing a total of 196 adverse events. The most commonly reported adverse events to patients were infection (n=50, 34.2%), neuropraxia (n=22, 15.1%) and hematoma/seroma (n=17, 11.6%). A total of 83 adverse events (42.3%) required reoperation. The most common reoperations performed for adverse events to patients were explantation (n=30, 46.2%) and device repositioning/lead revision (n=24, 36.9%), while the most common reoperation performed for device malfunctions was device replacement (n=10, 55.6%). In attempting to further improve patient compliance, understanding these device malfunctions and adverse events related to HNS implantation or usage is crucial for the identification of potential causes of patient non-adherence.

Comparison of Early Fatigue Failure of the TFNa and Gamma 3 Cephalomedullary Nails in the United States From 2015 to 2019.

To compare reports of implant fatigue failure submitted to the FDA of 2 commonly used cephalomedullary nails. In total, 2724 medical device reports from the FDA's MAUDE database from Jan 2015 to Oct 2019 were reviewed for the Trochanteric Femoral Nail-Advanced (TFNa) and Gamma 3 implants. Data from 342 implant failures included in the MAUDE database were analyzed. TFNa and Gamma 3 had 183 and 159 reported fatigue failures, respectively. All failed implants fractured in the same location through the proximal screw aperture. Time from implantation to failure was on average 2 months shorter for TFNa implants that were reported fractured than for Gamma 3 implants reported, a difference that was statistically significant (P < 0.05). In total, 100 implants were reported to have failed within the first 4 months (53 and 47 for TFNa and Gamma 3, respectively). For Gamma 3 implants that failed in the first 4 months, almost all of the available manufacturers' inspection reports revealed implant notches at the point of failure from drilling. For TFNa implants that failed early, only one reported notch was noted in the available inspection reports. In contrast to other studies regarding fatigue failure, reported failures in both TFNa and Gamma 3 occurred earlier than can be attributed to delayed or nonunion. The reported failures of the TFNa in the MAUDE database occurred earlier than did those of the Gamma 3. Early failures of the Gamma 3 seemed to be the result of iatrogenic implant notching. Therapeutic Level III. See instructions for authors for a complete description of levels of evidence.

Temporal Trends of Urogynecologic Mesh Reports to the U.S. Food and Drug Administration.

To compare temporal trends of urogynecologic mesh medical device reports with sentinel U.S. Food and Drug Administration (FDA) notices and to examine all linked reports of patient death. The Reed Tech Navigator is an online tool used to extract and analyze data in the Manufacturer and User Facility Device Experience database. We used FDA product codes to search for reports of synthetic mesh for stress urinary incontinence (SUI) and pelvic organ prolapse (POP). Reports with "death" listed as a patient event were queried further. There were 43,970 medical device reports involving urogynecologic mesh reported to the FDA between August 2000 and January 2019, with most occurring after the 2011 FDA communication (n=43,018, 97.8%). Of these medical device reports, 64.6% (n=28,422) were for SUI products, 27.0% (n=11,876) were for transvaginal POP products, and 8.4% (n=3,672) were for transabdominal POP products. Peak reporting occurred in 2013, which corresponded with the first major plaintiff verdicts and class action vaginal mesh settlement. There were 645 (1.5%) medical device reports of death, with 49.3% (n=318) having no cause of death identified. Only four (0.6%) could be directly attributed to the initial surgery. Since 2011, urogynecologic mesh has been the focus of thousands of medical device reports annually, although the data submitted are often incomplete. Few reported deaths are directly attributable to mesh products, and the majority lack sufficient information to draw causal conclusions. A high-quality registry is necessary to improve our understanding of the patient effect from urogynecologic mesh products.

MP40-01 ADVERSE EVENTS ASSOCIATED WITH SYNTHETIC MALE SLINGS: AN ANALYSIS OF THE FDA MAUDE DATABASE

You have accessJournal of UrologyUrodynamics/Lower Urinary Tract Dysfunction/Female Pelvic Medicine: Male Incontinence: Therapy I (MP40)1 Apr 2020MP40-01 ADVERSE EVENTS ASSOCIATED WITH SYNTHETIC MALE SLINGS: AN ANALYSIS OF THE FDA MAUDE DATABASE Hanson Zhao*, Colby P. Souders, Kai Dallas, Paige Kuhlmann, Karyn Eilber, and Jennifer T. Anger Hanson Zhao*Hanson Zhao* More articles by this author , Colby P. SoudersColby P. Souders More articles by this author , Kai DallasKai Dallas More articles by this author , Paige KuhlmannPaige Kuhlmann More articles by this author , Karyn EilberKaryn Eilber More articles by this author , and Jennifer T. AngerJennifer T. Anger More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000000889.01AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: The controversy and scrutiny towards polypropylene transvaginal mesh for pelvic organ prolapse has had significant repercussions towards the usage and perception of mid-urethral slings for stress urinary incontinence in women. We aim to explore whether there has been a similar effect for synthetic polypropylene male slings by analyzing the adverse events associated with male slings reported to the FDA Manufacturer and User Facility Device Experience (MAUDE) database. METHODS: We queried the MAUDE database for all entries with the brand name “Male Sling,” “Invance,” “Virtue,” or “Advance” from January 1st, 2009 to December 31st, 2018. We collected and analyzed information about the event type, date received, report source, source type, manufacturer, and event description text. Duplicate entries were removed. RESULTS: A total of 497 adverse events related to the male sling were identified. The adverse events were classified on the MAUDE database as injury (95.4%), malfunction (4.2%), and other (0.4%). There were no deaths reported. The slings involved were the Advance or Advance XP (69.8%), Invance (15.5%), Virtue Quadratic (12.3%), or unknown (2.4%). There was no increase in medical device reports (MDRs) from 2011 and 2012 after the FDA safety communication. On review of the event description texts, a total of 232 (47%) events were related to urinary incontinence after sling placement. Other events included sling erosion (9%), mechanical malfunction (8%), pain or numbness (8%), infection (7%), urinary retention (5%), bladder or urethral injury (3%), or were unknown (13%). The report source was from a manufacturer for 490 (98.6%) reports. The rest were from a user facility (n=4) or voluntary (n=3). The source type was reported to be from a health care professional for 428 (86%) reports, consumer for 33 (7%) reports, or other for 36 (7%) reports. There were no reports generated by attorneys. CONCLUSIONS: There are a modest number of MDRs related to male slings and almost half of them describe persistent urinary incontinence. The reporting of adverse events for male slings does not seem to be affected by the controversy toward transvaginal mesh and mid-urethral slings. Further work needs to investigate the safety of polypropylene slings for urinary incontinence. Source of Funding: None © 2020 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 203Issue Supplement 4April 2020Page: e585-e585 Advertisement Copyright & Permissions© 2020 by American Urological Association Education and Research, Inc.MetricsAuthor Information Hanson Zhao* More articles by this author Colby P. Souders More articles by this author Kai Dallas More articles by this author Paige Kuhlmann More articles by this author Karyn Eilber More articles by this author Jennifer T. Anger More articles by this author Expand All Advertisement PDF downloadLoading ...

The Compounding Power of the Clinical Community

Healthcare technology management (HTM) professionals are critical stakeholders in promoting patient safety, regularly troubleshooting medical devices that are unsafe or unable to be used by clinical staff. Healthcare technology management professionals determine, investigate, and often address the root cause (or causes) of medical device concern(s), so that the devices can be used safely and effectively throughout the facility. The HTM professional's investigation, when accompanied by medical device reports, often leads to manufacturer actions, including recalls and corrections, which contribute to continuous improvement of device safety and performance. As highlighted in this case report, healthcare facility reporting teams, which include HTM professionals, provide value to the healthcare community as a whole, affecting real-world outcomes and patient safety.

Descriptive analysis of postmarket surveillance data for hip implants.

PurposeRecent safety issues involving medical devices have highlighted the need for better postmarket surveillance (PMS) evaluation. This article aims to describe and to assess the quality of the PMS data for a medical device and, finally, to provide recommendations to improve the data gathering process.MethodsA descriptive analysis of medical device reports (MDRs) on the use of MRA, a specific type of hip implant replacement submitted to the Food and Drug Administration Manufacturer and User Facility Device Experience database from 1 January 2008 to 31 December 2017. The number of reports was described as the number of MDRs per unique MDR number and stratified by different variables. The quality was assessed by the level of completeness of the collected PMS data.ResultsThe total number of reports related to MRA was 2377, and the number of MDRs per year ranged between 84 in 2009 and 452 in 2017. Most of the reports were reported by manufacturer Depuy Johnson & Johnson and were reported by a physician. In 44.9% of the reports, the device problem was reported as “Unknown.” When the device problem was known, in the majority of cases, it was related to an implant fracture. The quality of the collected data was assessed as low due to missing information.ConclusionThe underlying data should meet high quality standards to generate more evidence and to ensure a timely signal generation. This case study shows that the completeness and quality of the MDRs can be improved. The authors propose the development of tools to ensure a more dynamic complaint data collection to contribute to this enhancement.