(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) 2016.(b)(4) submitted for adverse event which occurred on (b)(6) 2017.(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) 2015 and mesh was implanted.It was reported that the patient underwent removal surgery and recurrent umbilical hernia repair surgery on (b)(6) 2016 and mesh was implanted.It was reported that the patient underwent recurrent hernia repair surgery on (b)(6) 2017 and (b)(6) 2019.It was reported that the patient experienced severe pain, nausea, physical deformity, inflammation, revision surgery, loss of appetite, weakness, stress and anxiety.Other procedure is captured under separate file.No additional information was provided.
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