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) 2011.(b)(4) 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) 2008 and mesh was implanted.It was reported that the patient underwent hernia repair surgery on (b)(6) 2011 and mesh was implanted.It was reported that the patient underwent removal surgery on (b)(6) 2012.It was reported that the patient experienced severe and chronic pain/discomfort, inflammation, adhesions, abdominal wall reconstruction, scarring, adhesions to bowel and adhesions to small intestine.Other procedure is captured under separate file.No additional information was provided.
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