It was reported by an attorney that the patient underwent ventral hernia repair on (b)(6)2008 and mesh was implanted.It was reported that the patient underwent partial removal of mesh on (b)(6) 2013 due to pain, bowel perforation, abdominal wall abscess, infection, adhesions.It was reported that the patient underwent partial removal surgery on (b)(6) 2017 due to pain, inflammation, necrosis, infection, fistula.It was reported that the patient had a mesh implanted on (b)(6) 2008 which was captured in a separate file.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) 2013.(b)(4) submitted for adverse event which occurred on (b)(6) 2017.
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