Concomitant product: pco12 parietex comp 3d py 12 cir nothr (lot # pld00041), pco20x parietex pcox rnd 20cm x1 (lot # pmc00243), unknown absorbatack (lot # unknown).If information is provided in the future, a supplemental report will be issued.
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The patient¿s attorney alleged a deficiency against the device.The product was used for laparoscopic therapeutic treatment of an incisional hernia and an umbilical hernia.It was reported that after the implant, the patient experienced adhesions, infected mesh, wound dehiscence, abscess, abdominal pain, and recurrence.Post-operative patient treatment included removal of incision and drainage, lysis of adhesions, intra-abdominal sutures, extirpation of infected mesh, and removal surgery.
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