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) 2018.(b)(4) 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) 2018 and mesh was implanted.It was reported that the patient underwent removal surgery and hernia repair surgery on (b)(6) 2018 and mesh was implanted.It was reported that the patient underwent removal surgery on (b)(6) 2020 during which the surgeon noted there was intra-abdominal mesh adherent to the abdominal wall and the underlying omentum requiring full mobilization for mesh removal.The omentum was densely adherent and required skilled care to preserve the omentum and bulbous fashion.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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