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) 2016.(b)(4) submitted for adverse event which occurred on (b)(6) 2020.
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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 hernia repair surgery on (b)(6) 2016 and mesh was implanted.It was reported the patient underwent removal surgery on (b)(6) 2020.It was reported that the patient experienced pain, nausea, diarrhea, chills, inflammation, bleeding, dense adhesions, adhesions to the bowel and small intestine, and seroma.Other procedure is captured under separate file.No additional information was provided.
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