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) 2008.(b)(4) submitted for adverse event which occurred on (b)(6) 2009.
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It was reported by an attorney that the patient underwent hernia repair surgery on (b)(6) 2007 and mesh was implanted.It was reported that the patient underwent incisional hernia repair on (b)(6) 2008 during which the surgeon noted the mesh had pulled loose from the lower incision and a large hernia defect was present.It was reported that the patient underwent hernia repair surgery on (b)(6) 2009 during which the surgeon noted multiple adhesions of the mesh with the anterior abdominal wall and adhesions with the omentum.It was reported that the patient experienced severe pain, nausea, diarrhea, chills, inflammation, loss of appetite and extreme weight loss.No additional information was provided.
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