(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.Mwr-28042022-0001174650 submitted for adverse event which occurred on (b)(6) 2012.Mwr-28042022-0001174649 submitted for adverse event which occurred on (b)(6) 2015.
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It was reported by an attorney that the patient underwent hernia repair surgery on (b)(6) 2012 and mesh was implanted.It was reported that the patient underwent removal surgery and recurrent hernia repair surgery on (b)(6) 2012 and mesh was implanted.It was reported that the patient underwent removal surgery on (b)(6) 2015 during which the surgeon noted the mesh had separated from the fascia where massive adhesions that were meticulously dissected.It was reported that the patient experienced severe pain, nausea, diarrhea, chills, inflammation, loss of appetite and extreme weight loss.Other procedure is captured under separate file.No additional information was provided.
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