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 and hernia repair surgery and mesh was implanted on (b)(6) 2018 during which the surgeon noted it had detached itself from the left abdominal wall and had become balled up in a mass of omentum and surgical tacks necessitating total explantation of the mesh.It was reported that the patient underwent removal surgery on (b)(6) 2020 during which the surgeon noted a sinus tract associated with mesh in additional intraabdominal adhesions.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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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) 2018.Mwr(b)(4) submitted for adverse event which occurred on (b)(6) 2020.
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