(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) 2007.(b)(4) submitted for the adverse event which occurred on (b)(6) 2011.
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It was reported by an attorney that the patient underwent hernia repair surgery on (b)(6) 2007 and mesh was implanted.It was reported that the patient underwent removal surgery and debridement of abdominal wall abscess on (b)(6) 2007 during which the surgeon noted ¿a big mass formation with the cystic area with large amount of fluid in the cavity, which was excised, along with the previously placed mesh.Debridement was done around the tissue.A wound vac was placed in order to try to clear the fluid formation in the debridement and a plastic dressing was placed.¿ it was reported that the patient underwent recurrent hernia repair, exploratory laparotomy, lysis of adhesions, debridement of abdominal wall, and small bowel obstruction on (b)(6) 2011 during which the surgeon noted ¿the small bowel was densely adherent to the previously placed mesh.There was a purulent fluid encountered consistent with abscess and infection of the anterior abdominal wall mesh.The mass was then excised.¿ it was reported that the patient experienced severe pain, infection, abscess, fistula, bulging, inflammation, stress and anxiety.No additional information was provided.
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