The patient¿s attorney alleged a deficiency against the device.
The product was used for therapeutic treatment of an incisional hernia.
It was reported that after implant, the patient experienced an open wound, (b)(6), recurrence, prostatic calcifications, atrophy of the right-sided rectus muscle of the anterior abdominal wall, bulging, serous discharge, seroma, pain, wound infection, dehisced surgical wound, hematoma, coughing, night sweats, adhesions, lump, abdominal pain, tenderness, hard/nodular mass, scar tissue, loss of domain, loss of integrity of anterior abdomen, gangrene on the right scrotum, and lipoma.
Post-operative patient treatment included revision surgery, incision/drainage of wound, antibiotics, wound vac, excision of dehisced surgical wound, evacuation hematoma, reconstruction rlq, debridement, reconstruction by elevation and transposition of bilateral fasciocutaneous advancement flaps, hernia repair with new mesh, resection horizontally-oriented unstable scar deformity/redundant epidermis/dermis/subcutaneous tissue/fascia within the rlq of anterior abdominal wall measuring, hernia repair with components separation rectus abdominus muscle flaps based upon the inferior epigastric and superior epigastric neurovascular bundles, tissue rearrangement, hernia sac removed, transposition of the rectus abdominus muscle flap for reconstruction of fournier¿s gangrene on the right scrotum, and medication.
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