(b)(4).To date, the device has not been returned.If the product is returned for evaluation, any further information derived from the evaluation will be submitted in a supplemental 3500a form.(b)(4) submitted for adverse event which occurred on (b)(6) 2007.(b)(4) submitted for adverse event which occurred on (b)(6) 2019.
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It was reported by an attorney that the patient underwent hernia repair surgery on (b)(6) 2005 and mesh was implanted.It was reported that the patient underwent hernia repair surgery on (b)(6) 2007 during which the surgeon noted extensive bowel adhesions and a hernia inferior to the old ventral hernia repair.The extensive adhesions were taken down.It was reported that the patient underwent surgery on (b)(6) 2019 during which the surgeon noted the mesh firmly adherent to bowel loops with multiple areas in which the small bowel and mesh were fused.After several hours of tedious dissection, an area of perforated small bowel with puss and stool content were discovered.He resected the small bowel and repaired multiple areas of deserosalization that occurred during the extensive lysis of adhesions.The abscess cavity was irrigated and the sharp edges of any exposed mesh were debrided.It was reported that the patient experienced severe pain, nausea, diarrhea, chills, inflammation, loss of appetite and extreme weight loss.No additional information was provided.
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