(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.(b)(4) represents the adverse event which occurred on (b)(6) 2013.(b)(4) represents the adverse event which occurred on (b)(6) 2013.
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It was reported by an attorney the patient underwent removal surgery and hernia repair surgery on (b)(6) 2011 and mesh was implanted.It was reported the patient underwent removal surgery on (b)(6) 2013.It was reported that the patient underwent revision surgery on (b)(6) 2013.It was reported that the patient experienced severe and chronic pain/discomfort, inflammation, dense adhesions, adhesions to bowel, mesh detachment and abdominal wall fluid collection.The patient had a previous mesh implanted on (b)(6) 2011 which is captured in a separate file.No additional information was provided.
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