It was by an attorney reported that the patient underwent hernia repair surgery on (b)(6)2010 and mesh was implanted.It was reported that the patient underwent removal surgery and recurrent hernia repair surgery on (b)(6)2011 and mesh was implanted during which the surgeon noted the mesh was wadded up and lodged inferiorly and to the left side of the old defect.The mesh was removed.It was reported that the patient underwent removal surgery on (b)(6)2013 during which the surgeon noted the hernia had recurred and that there were some adhesions of bowel to the inside portion of the fascia.It was reported that the patient experienced severe pain, nausea, diarrhea, chills, inflammation, loss of appetite and extreme weight loss.Other procedure is captured under 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)2011.(b)(4) submitted for adverse event which occurred on (b)(6)2013.
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