A review of the complaint device history records indicated that the patch was processed and inspected according to established procedures and was therefore released following acceptable quality inspections and tests.Specifically, these tests include mechanical strength tests (longitudinal tensile strength and 45° and 90° suture retention strength) and 100% visual control.The actual device was cut out before returning to the manufacturer and was received incomplete in a bottle bathing in undefined liquid.Hence, evaluation of the edges in order to confirm fraying is impossible.Three other sealed products from same lot (including two patches from same intermediate product) were returned with the complaint device and were visually inspected.No anomaly was found.The complaint cannot be confirmed due to the condition of the received device which makes evaluation impossible.However, the conducted investigation would tend to indicate that the product was not defective at the time of manufacturing.
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