(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 adverse event which occurred on (b)(6) 2014.(b)(4) submitted for adverse event which occurred on (b)(6) 2014.(b)(4) submitted for adverse event which occurred on (b)(6) 2019.
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It was reported by an attorney that the patient underwent hernia repair surgery on (b)(6) 2014 and mesh was implanted.It was reported that the patient underwent hernia repair surgery on (b)(6) 2014 and mesh was implanted.It was reported that the patient underwent recurrent ventral hernia repair surgery on (b)(6) 2014 during which the surgeon noted interoperatively, he noted that the peritoneal tissue was densely scarred to the posterior surface of the prior mesh.It was reported that the patient underwent removal surgery, recurrent incisional hernia repair surgery, extensive lysis of adhesions, scar revision and bilateral myofascial advancement of flaps on (b)(6) 2019 during which the surgeon released all the adhesions and removed the old synthetic mesh.It was reported that the patient experienced severe pain, dense adhesions, scarring, nausea, chills, inflammation, loss of appetite, weight loss, stress and anxiety.Other procedures are captured under separate files.No additional information is provided.
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