Concomitant medical products: pco9 parietex comp 3d py 9 cir no thrx1 (lot# pij00348), pco15 parietex comp 3d py 15 cir nothr (lot# pic00371), unknown absorbatack (lot# unknown).(b)(4).If information is provided in the future, a supplemental report will be issued.
|
The patient¿s attorney alleged a deficiency against the device.The product was used for laparoscopic therapeutic treatment of an incisional hernia.It was reported that after implant, the patient experienced recurrence, adhesions, enlarging lump, erythema, pain, purulent material, and abscess.Post-operative patient treatment included revision surgery, adhesiolysis, and incision and drainage of a stitch abscess with removal of ethibond suture.
|