Concomitant medical products: pco20, lot number: plb00291; pco12x , lot number: plh00283.
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 incarcerated incisional hernias.
It was reported that after a procedure where this device was implanted, the patient experienced multiple surgical revisions, recurrent incarcerated incisional hernias requiring placement of new mesh for repair, dense adhesions (lysed over 2.
5 hours), enterotomy repair, effaced bowel, excision, infection, abdominal abscess, small bowel perforation, foul-smelling puss from abdominal wound, placement of wound vac because they were unable to close the abdominal wall d/t bowel perforation and open wound, primary repair of small bowel perforation and exchange of wound vac, abdominal wound sepsis, wound exploration, removal of wound vac, incision and drainage of right lateral abdominal wall, placement of new mesh to repair defect, small bowel obstruction.
After treatment, the patient experienced revision surgery.
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