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) 2017.Mwr-(b)(4) submitted for adverse event which occurred on (b)(6) 2018.
|
It was reported by an attorney that the patient underwent hernia repair surgery on (b)(6) 2017 and mesh was implanted.It was reported that the patient underwent recurrent hernia repair surgery on (b)(6) 2017 during which the surgeon noted adhesions which were taken down and then another defect.It was reported that the patient underwent removal surgery and recurrent hernia repair surgery on (b)(6) 2018 during which the surgeon noted omentum and small bowel adhesions, seroma and a recurrent hernia.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.
|