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 partial removal surgery on (b)(6) 2014 during which the surgeon noted a portion of the mesh at the base of the wound abscess.It was reported that the patient underwent partial removal surgery on (b)(6) 2014 during which the surgeon noted there was inflammatory tissue at the base of the wound involving the mesh.He then excised all visible mesh but left a significant amount in due to incorporation.It was reported the patient underwent partial removal surgery on (b)(6) 2014 during which the surgeon noted he was able to remove all the mesh on the left side of the peritoneal cavity, despite adhesions, and he then discovered a portion of the mesh was intraluminal to her small bowel, with resulting small bowel to mesh fistula, necessitating a small bowel resection.It was reported that the patient experienced severe pain, nausea, diarrhea, chills, inflammation, loss of appetite and has a large dense in her abdomen due to multiple surgeries and infections.¿ no additional information was provided.
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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.Mwr# (b)(4), submitted for adverse event which occurred on (b)(6) 2014.Mwr# (b)(4), submitted for adverse event which occurred on (b)(6) 2014.Mwr# (b)(4), submitted for adverse event which occurred on (b)(6) 2014.
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