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) 2009.(b)(4) submitted for adverse event which occurred on (b)(6) 2010.(b)(4) submitted for adverse event which occurred on (b)(6) 2010.
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It was reported by an attorney that the patient underwent hernia repair surgery on (b)(6) 2009 and mesh was implanted.It was reported that the patient underwent removal surgery on (b)(6) 2009 and mesh was implanted during which the surgeon noted significant blood superior to the mesh.The mesh was removed exposing a large hematoma, which was evacuated.It was reported that the patient underwent removal surgery on (b)(6) 2010 during which the surgeon noted there were loops of bowel adherent to the mesh, the lysing of which resulted in perforation of the bowel.The contaminated mesh was removed with great care to cause the least amount of trauma to the abdominal wall as possible.It was reported that the patient underwent a surgical procedure on (b)(6) 2010.It was reported that the patient experienced severe pain, nausea, diarrhea, chills, inflammation, loss of appetite and extreme weight loss.Other procedure is captured under separate file.No additional information was provided.
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