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-15072022-0001221695 submitted for adverse event which occurred on (b)(6) 2011.Mwr-15072022-0001221696 submitted for adverse event which occurred on (b)(6) 2012.
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It was reported by an attorney that the patient underwent hernia repair surgery on (b)(6) 2011 and mesh was implanted.It was reported that the patient underwent partial removal surgery on (b)(6)2011.It was reported that the patient underwent removal surgery on (b)(6) 2012.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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