(b)(4).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) 2012.(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) 2011 and mesh was implanted.It was reported that the patient underwent removal surgery and hernia repair surgery on (b)(6) 2012 and mesh was implanted during which the surgeon noted the mesh was torn, wad debrided and removed.It was reported that the patient underwent removal surgery and hernia repair surgery on (b)(6) 2012 and mesh was implanted during which the surgeon noted he lysed the small bowel adhesions to the mesh.He noted the mesh had become detached and removed the mesh.It was reported that the patient experienced severe pain, torn mesh, discomfort, nausea, diarrhea, chills, inflammation, loss of appetite and extreme weight loss.The other procedures are captured in separate files.No additional information was provided.
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