This information was received as a part of an extensive mesh litigation submission to medtronic.
the fda was notified of this large complaint receipt.
due to the volume of complaint information received by medtronic, this resulted in a report beyond the 30 day target.
If information is provided in the future, a supplemental report will be issued.
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This information was received as a part of an extensive mesh litigation submission to medtronic.
the fda was notified of this large complaint receipt.
due to the volume of complaint information received by medtronic, this resulted in a report beyond the 30 day target.
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 therapeutic treatment of a ventral incisional hernia.
It was reported that after implant, the patient experienced dense adhesions, subserosal tissues associated with fibrosis, granulomatous foreign body reaction, weight loss, panniculus, and fistula.
Post-operative patient treatment included small bowel re section, abdominal panniculectomy, lap and open ventral hernia repair, separation of components with mobilization of skin flaps with tissue rearrangement, small bowel resection, repair of colotomy, lap to open ventral hernia repair, placement of ventralight mesh, mobilization of skin flaps, tissue arrangement, complex wound closure, mesh explanation, mobilization of tissue flap, complex wound closure and lysis of adhesions relevant tests/laboratory data, including dates: (b)(6) 2014: pathology report- small bowel shows foreign material in subserosal tissues associated with fibrosis and granulomatous foreign body reaction probably representing mesh material.
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