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-30032022-0001157835 submitted for adverse event which occurred on (b)(6) 2020.Mwr-30032022-0001157834 submitted for adverse event which occurred on (b)(6) 2020.
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It was reported by an attorney that the patient underwent hernia repair surgery on (b)(6) 2017 and mesh was implanted.It was reported that the patient underwent removal surgery and recurrent hernia repair surgery on (b)(6) 2020 during which the surgeon noted the mesh appeared to be somewhat shrunken and was densely adherent to the small bowel.After extensive lysis of adhesions, he explanted the free floating mesh.It was reported that the patient underwent revision surgery and removal surgery on (b)(6)2020 during which the surgeon noted he divided the mesh off the abdominal wall land explanted the mesh.It was reported that the patient experienced severe pain, nausea, diarrhea, chills, inflation, loss of appetite and extreme weight loss.No additional information was provided.
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