Reference number: (b)(4).Based on sample examination, the involved product is a pco6vp with lot #rpi0119x.A review of the device history record has been performed.This review confirmed that this lot of products was reviewed and released according to qa specifications, including the manufacturing records related to the collagen film casting, drop off the textile and drying, and the manufacturing records related to the films cutting were found within specifications.The visual examination of the returned sample shows the following: the sample was returned in its original packaging.The box and consumer labels indicate that the lot number is rpi0119x.Mesh dimensions, textile knitting and handles positioning were found as expected.The collagen film was found dry with traces of blood next to one junction of the violet expanders.The overlap of the collagen film was found gathered on the visceral side (collagen based film).One piece of the collagen film overlap was broken.After rehydration of the film with saline solution as required per the product instructions for use (ifu), the collagen film was found as expected except at the break location.It has been concluded, by visual examination, that excessive manipulation could have induced the break of the piece of the collagen film overlap.After rehydration, no other anomalies were observed regarding the collagen film.The product ifu indicates that the patch must be hydrated in its original blister before being handled.This is carried out by immersing it completely in sterile saline solution for several seconds in order for it to recover its conformability and flexibility.Based on our investigation, the manufacture of the device is not suspected.There is no indication that there is a defective lot or that this event represents an emerging adverse quality trend.(b)(4).
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