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 recurrent hernia repair surgery on (b)(6) 2012 and mesh was implanted during which the surgeon noted a defect was noted in the inferior/lateral aspect where the mesh was not adhered to the abdominal wall.It was reported that the patient underwent revision surgery on (b)(6) 2012 during which the surgeon noted the mesh was palpated inferiorly and seemed to have pulled away in this area.It was reported that the patient underwent removal surgery and recurrent hernia repair surgery on (b)(6) 2013 and mesh was implanted during which the surgeon noted we did encounter a couple different layers of mesh in this area.It was inferiorly again where this appeared to have pulled free.Anteriorly, the mesh was identified as a thickened very fibrotic mass.Eventually during the procedure, we ended up removing pretty much all of this in its entirety.It was reported that the patient underwent removal surgery on (b)(6) 2016 during which the surgeon noted the mesh was identified in the lower abdomen and there was bowel adherent to the mesh and the pro-tak coils.A lysis of adhesions was done circumferentially to free the bowel from the mesh.The mesh and all foreign material was removed from the abdomen.It was reported that the patient underwent removal surgery on (b)(6) 2018.It was reported that the patient experienced severe pain, nausea, diarrhea, chills, inflammation, loss of appetite and extreme weight loss.It was reported that the patient had hernia repair surgery on (b)(6) 2011 and mesh was implanted.Other procedure is captured under separate file.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-22032022-0001152146 submitted for adverse event which occurred on (b)(6) 2012.Mwr-22032022-0001152145 submitted for adverse event which occurred on (b)(6) 2012.Mwr-22032022-0001152144 submitted for adverse event which occurred on (b)(6) 2013.Mwr-22032022-0001152143 submitted for adverse event which occurred on (b)(6) 2016.Mwr-22032022-0001152142 submitted for adverse event which occurred on (b)(6) 2018.
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