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 an unknown date.(b)(4) 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) 2013 and mesh was implanted.It was reported that the patient underwent removal surgery during which the surgeon noted ¿the mesh was found to be separated on the superior right lateral side and had reflected inferiorly on the left.It was reported that the patient underwent revision surgery on (b)(6) 2018 during which the surgeon noted ¿there was a large amount of adhesions to the small bowel and omentum to the abdominal wall.¿ it was reported that the patient experienced severe pain, nausea, diarrhea, chills, inflammation, loss of appetite and extreme weight loss.No additional information was provided.
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