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 on (b)(6) 2019 during which the surgeon noted the mesh had displaced and was removed.It was reported that the patient underwent removal surgery on an unk date.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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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 10/9/2019.(b)(4) submitted for adverse event which occurred on unk date.
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