Date sent to the fda: 27-mar-2021
h6: appropriate term / code not available (e2402) utilized to capture seromuscular tear.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.
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It was reported by an attorney that the patient underwent a hernia repair surgery on (b)(6) 2014 and mesh was implanted.It was reported that the patient underwent partial removal surgery on (b)(6) 2017.It was reported that the patient experienced severe and chronic pain/discomfort, scarring, dense adhesions, small bowel densely adherent to the mesh, seromuscular tear, bowel resection, chronic small bowel obstruction, foreign body reaction, scarring and abdominal wall reconstruction.No additional information was provided.
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