It was reported by an attorney that the patient underwent hernia repair surgery on an unk date and two (2) mesh products were implanted.It was reported that the patient underwent removal surgery and recurrent hernia repair surgery on (b)(6) 2017 and mesh was implanted.It was reported that the patient underwent removal surgery on (b)(6) 2019.It was reported that the patient experienced severe pain, nausea, diarrhea, chills, inflammation, loss of appetite and extreme weight loss.The other procedure is captured in a separate file.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 (b)(6) 2017.(b)(4) submitted for adverse event which occurred on (b)(6) 2019.
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