(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.Mwr-(b)(4) submitted for adverse event which occurred on (b)(6) 2015.Mwr-(b)(4) submitted for adverse event which occurred on (b)(6) 2019.A review of the batch manufacturing records was conducted and the batch met all finished goods release criteria.
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It was reported by an attorney that the patient underwent hernia repair surgery on (b)(6) 2015 and mesh was implanted.It was reported that the patient underwent revision surgery on (b)(6) 2015.It was reported that the patient underwent revision surgery on (b)(6) 2019.It was reported the patient experienced pain, inflammation, adhesions, adhesions to the small intestine and bowl, small bowel had tearing and damage, bowel resection, scarring, and abdominal wall reconstruction.No additional information was provided.
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