(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) 2013.(b)(4) submitted for adverse event which occurred on (b)(6) 2015.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) 2012 and mesh was implanted.It was reported the patient underwent revision surgeries on (b)(6) 2013 and (b)(6) 2015.It was reported that the patient experienced pain, inflammation, adhesions, mesh detachment, and revision.No additional information was provided.
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