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) 2013.(b)(4) submitted for adverse event which occurred on (b)(6) 2014.
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It was reported by an attorney that the patient underwent hernia repair surgery on (b)(6) 2006 and mesh was implanted.It was reported that the patient underwent removal surgery and recurrent hernia repair surgery on (b)(6) 2013.It was reported that the patient underwent removal surgery on (b)(6) 2014 during which the surgeon noted the patient complained of draining fistula tract for years, along with pain, abscess and infections.He chose to remove the infected mesh during his exploratory laparotomy, lysis of adhesions, resection of enterocutaneous fistula and small bowel resection.It was reported that the patient experienced severe pain, nausea, diarrhea, chills, inflammation, loss of appetite and infections.No additional information was provided.
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