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.Mwr-(b)(4) submitted for adverse event which occurred on (b)(6) 2016.Mwr-(b)(4) submitted for adverse event which occurred on (b)(6) 2016.Mwr-(b)(4) submitted for adverse event which occurred on (b)(6) 2016.
|
It was reported by an attorney that the patient underwent hernia repair surgery on (b)(6) 2013 and mesh was implanted.It was reported that the patient underwent revision surgery on (b)(6) 2016 during which the surgeon noted several loops of bowel densely adherent to the mesh.He lysed the adhesions but a portion of the mesh remained adhered to the bowel.It was reported that the patient underwent revision surgery on (b)(6) 2016.It was reported that the patient underwent revision surgery on (b)(6) 2016.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.
|