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-28012021-0000886228 submitted for the adverse event which occurred on (b)(6) 2012.Mwr-28012021-0000886235 submitted for the 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 on (b)(6) 2012 during which the surgeon noted ¿no question that the mesh was in fact involved in the abscess cavity and the mesh was necessarily removed.¿ it was reported that the patient underwent hernia repair surgery on (b)(6) 2015 and mesh was implanted.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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