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) 2015.(b)(4) submitted for adverse event which occurred on (b)(6) 2019.(b)(4) submitted for adverse event which occurred on (b)(6) 2020.
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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 revision surgery on (b)(6) 2015 during which the surgeon noted after extensive adhesiolysis of over two hours, he noted that the draining fistula was still present, with some of the prosthetic mesh in this location.He cut out the fistula and mesh at a level that did not appear to be part of the inflammatory process.It was reported that the patient underwent removal surgery and revision surgery on (b)(6) 2019 during which the surgeon noted a pocket of infected fluid and discovered deep within he tissue an approximately 10 cm piece of mesh.He drained the fluid and removed the mesh.It was reported that the patient underwent another removal surgery on (b)(6) 2020 during which the surgeon noted he encountered a pocket of murky fluid which led to a thickened area of chronically infected mesh.Removing the mesh in its entirety required him to create a much larger opening in the abdomen.After enhancing the size of the wound, he was able to remove the mesh.It was reported that the patient experienced non-healing wounds, severe pain, bowel obstruction, nausea, diarrhea, chills, inflammation, loss of appetite and extreme weight loss.No additional information was provided.
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