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) 2020.(b)(4) submitted for adverse event which occurred on (b)(6) 2021.
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It was reported by an attorney that the patient underwent hernia repair surgery on (b)(6) 2007 and mesh was implanted.It was reported that the patient underwent l surgery on (b)(6) 2020 during which the surgeon noted enterocutaneous fistula takedown and closure, extensive lysis of adhesions lasting greater than one hour removal of abdominal wall foreign body and wound vac placement.It was reported that the patient underwent removal surgery on (b)(6) 2021 during which the surgeon noted the small bowel needed to be removed, extensive lysis of adhesions and removal of mesh.It was reported that the patient experienced severe pain, abdominal pain and discomfort, non-healing wound, nausea, diarrhea, chills, inflammation, loss of appetite and extreme weight loss.No additional information was provided.
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