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.Mwr-07072022-0001215877 submitted for adverse event which occurred on (b)(6) 2011.Mwr-07072022-0001215875 submitted for adverse event which occurred on (b)(6) 2018.
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It was reported by an attorney that the patient underwent hernia repair surgery on (b)(6) 2010 and mesh was implanted.It was reported that the patient underwent removal surgery on (b)(6) 2011 and hernia repair surgery and mesh was implanted, during which the surgeon noted the bowel was incorporated and adherent to the mesh that a portion of the mesh and bowel had to be removed.It was reported that the patient underwent extensive lysis of adhesions and small bowel resection on (b)(6) 2018 during which the surgeon noted bowel was adherent to the mesh, which resulted in the need to resection of portion of bowel.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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