(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) 2010.(b)(4) submitted for adverse event which occurred on (b)(6) 2018.
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It was reported by an attorney that the patient underwent hernia repair surgery on (b)(6) 2007 and mesh was implanted.It was reported that the patient underwent revision surgery on (b)(6) 2010.It was reported that the patient underwent removal surgery, hernia repair surgery, lysis of adhesions , creation of myocutaneous flaps and scar revision surgery on (b)(6)2018.It was reported that the patient experienced scar revision, severe pain, adhesions, nausea, vomiting, chills, inflammation, scarring, disfigurement, loss of appetite, stress and anxiety.No additional information is provided.
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