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) 2017.(b)(4) submitted for 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) 2015 and mesh was implanted.It was reported that the patient underwent recurrent hernia repair surgery on (b)(6) 2017 and mesh was implanted.It was reported that the patient underwent revision surgery on (b)(6) 2019 during which the surgeon noted the old mesh had pulled away from the right side of the hernia defect and that some of the mesh was in the hernia sac itself.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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