Date sent to the fda: 10/25/2022 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) 2019.Mwr-24102022-0001284883 submitted for adverse event which occurred on (b)(6) 2022.
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It was reported by an attorney that the patient underwent hernia repair surgery on (b)(6) 2013 and mesh was implanted.It was reported that the patient underwent removal surgery on (b)(6) 2019 during which the surgeon noted an approximately 3 cm round mesh that was well incorporated into the peritoneum just deep into the umbilicus.This was excised as was the umbilicus as it was no longer viable.The distal resection was mid transverse.It was reported that the patient underwent recurrent hernia repair surgery and lyse of adhesions on (b)(6) 2022.It was reported that the patient experienced severe pain, nausea, diarrhea, chills, inflammation, loss of appetite, bowel resection, chronic inflammation and extreme weight loss.No additional information was provided.
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