(b)(4).Concomitant product: securestrap (product id: strap25, lot no: lez828), securestrap (product id: strap25, lot no: lcm323), pco3728x parietex pcox 37x28cm x1 (lot# prc0045x), pco3728x parietex pcox 37x28cm x1 (lot# prc0045x).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 therapeutic treatment of a ventral hernia.It was reported that after the implant, the patient experienced exposed mesh, wound dehiscence, non-healing wound, chronic abdominal wound, erosion of mesh into bowel, mesh infection, fistula, recurrence, adhesions, abscess, seroma, poorly incorporated mesh, mesh migration, loss of domain, positive for pyoderma gangrenosum, sepsis, death, and necrotic tissue.Post-operative patient treatment included revision surgeries, mesh resutured, wound vac, wound debridement, removal of mesh, split-thickness skin graft, and hernia repair with new mesh, incision/drainage of abscess, evacuation of seroma, takedown of adhesions, small bowel resection, anastomosis, right flank abdominoplasty with advancement flaps of muscle and skin, transported to the icu, remained intubated because of long duration of open abdomen/comorbidities, and excision of necrotic tissue.Information received indicates the patient is now deceased, due to sepsis.
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