(b)(4).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) 2016.(b)(4) submitted for adverse event which occurred on (b)(6) 2019.
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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 revision surgery on (b)(6) 2016 and mesh was implanted.It was reported that the patient underwent laparoscopic lysis of adhesions on (b)(6) 2019 during which the surgeon noted a large significant amount of adhesions to the previously placed umbilical ventral patch.There was also small bowel tethered in the adehsions.This required extensive adhesiolysis.It was reported that the patient experienced severe pain, nausea, diarrhea, chills, inflammation, loss of appetite, and extreme weight loss.Other procedure is captured in a separate file.No additional information was provided.
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