Abstract
On behalf of Integral, a Sino-Australian Joint Venture manufacturer in China, and Fannin, the United Kingdom distributor, of the Integral® Silicone Reinforced Laryngeal Mask, I would like to address this serious but highly unusual report. Thorough investigation of the manufacture and distribution of this product has determined that this is an isolated incident. A full report has been submitted to the Medicines and Healthcare products Regulatory Agency and the case has been closed. We would like to reassure customers that production and distribution are conducted under strict quality management systems which do not permit the use of airguns in any situation. No incidents, discrepancies or evidence have identified the possible use of airguns in our manufacturing and distribution processes which included air freight. Airguns are prohibited in China and possession is subject to criminal prosecution. As a precaution all stocks of Integral product in the United Kingdom were checked and verified as undamaged. It was noted however during the investigation that on release from Fannin during transportation and following arrival at the hospital, access to the product is possible where tampering could occur. Integral is an ISO and FDA approved facility for the manufacture of medical devices and has been subject to audit on behalf of Fannin. Fannin is an ISO-approved and licensed pharmaceutical wholesaler in the United Kingdom using Medicines and Healthcare products Regulatory Agency approved premises only for storage and distribution purposes. Fannin and Integral are confident that this isolated incident must have occurred while outside both of our facilities but assure customers that we will continue to be vigilant in relation to this matter. Integral® Silicone Reinforced Laryngeal Masks are exported worldwide and Fannin has being selling these for several years. This is the first and only complaint of this nature received on this excellent high quality device that assists anaesthetists during their daily clinical practice.
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