Product complaint # (b)(4).A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.Additional information was requested and the following was obtained: please provide procedure name and date, open inguinal tuesday sept 7.Please clarify if there were any adverse patient consequences due to this event? if yes, please explain in detail, no adverse consequences because the product was not used.How was procedure successfully completed? opened another device.Please provide status of product return.No return.The product was returned to ethicon inc for evaluation.Visual inspection was conducted on the returned device.Visual analysis of the sample received determined that one top foil packet and an opened folder with the product was received for evaluation.The foil was visually inspected, and excessive wrinkles and a hole that appeared to be caused by the wrinkles was noted.As part of our quality process, the manufacturing records of this lot-serial number were reviewed, and the manufacturing standards were met prior to the release of this batch.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of post-market surveillance.
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