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 the adverse event which occurred on (b)(6) 2019.(b)(4) submitted for the adverse event which occurred on (b)(6) 2019.
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It was reported by an attorney that the patient underwent hernia repair surgery on (b)(6) 2013 and mesh was implanted.It was reported that the patient underwent revision surgery on (b)(6) 2019 during which the surgeon noted the patients' intraabdominal contents were significant adhesions to the patient¿s umbilical hernia mesh from her omentum.It was reported that the patient underwent revision surgery on (b)(6) 2019 during which the surgeon noted there were significant omental adhesions to the hernia mesh that were taken down.There were a dense inflammatory reaction and omental adhesions to the umbilical hernia mesh.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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