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 laparoscopy with lysis of adhesions on (b)(6) 2017 during which the surgeon noted the adhesions were taken down and two edges of the mesh were excised.It was reported that the patient underwent recurrent hernia repair surgery on (b)(6) 2019 during which the surgeon noted adhesions between the mesh and also a hernia recurrence directly through the previously placed mesh consistent with central mesh failure.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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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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