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) 2011.
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It was reported by an attorney that the patient underwent hernia repair surgery on (b)(6) 2005 and mesh was implanted.It was reported that the patient underwent revision surgery on (b)(6) 2011 during which the surgeon noted there he could see the edge of the mesh and there was just thick layer of adhesions of both omentum and intestines.It was reported that the patient underwent revision surgery on (b)(6) 2011 during which the surgeon noted that once the mesh had been freed up and we made sure we had established excellent hemostasis, we began taking down the adhesions of the small bowel to the mesh.Adhesions between the small bowel were actually quire few, but the mesh had actually eroded into at least two to three separate parts of the small intestine and the largest piece he was unable to dissect off of the intestines.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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