Date sent to the fda: 08/20/2021.(b)(4).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) 2013.(b)(4) submitted for the adverse event which occurred on (b)(6) 2017.
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It was reported by an attorney that the patient underwent hernia repair surgery on (b)(6) 2008 and mesh was implanted.It was reported that the patient underwent hernia repair surgery and lysis of adhesions on (b)(6) 2013 during which the surgeon noted ¿the previously placed mesh, which was noted to be densely adherent to the bowel.Extensive enterolysis was performed to divide and remove all the mesh from the bowel.A small area of deserosalization was repaired.¿ it was reported that the patient underwent removal surgery, small bowel resection, recurrent hernia repair surgery, lysis of adhesions and bilateral myocutaneous flap advancement on (b)(6) 2017.It was reported that the patient died on (b)(6) 2020 due to sepsis, small bowel obstruction with necrosis and perforation and incarceration of the small bowel.It was reported that the patient experienced severe pain, dense adhesions, bowel resection, bulging, inflammation, infection, stress, anxiety and death.No additional information was provided.
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