It was reported by an attorney that the patient underwent hernia repair surgery on (b)(6) 2004 and mesh was implanted.It was reported that the patient underwent revision surgery on (b)(6) 2005.It was reported that the patient underwent removal surgery on (b)(6) 2014 during which the surgeon noted infection, small bowel resection, sigmoid colon resection, fistula, and adhesions.It was reported that the patient experienced severe pain and inflammation.No additional information was provided.
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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) 2005.(b)(4) submitted for adverse event which occurred on (b)(6) 2014.
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