(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.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) 2014 and mesh was implanted.It was reported that the patient underwent left groin exploration with open left inguinal hernia repair on (b)(6) 2015 during which the surgeon noted he encountered the previously placed mesh which was balled up.It was reported that the patient experienced severe pain, mesh removal, nerve damage, scarring, stress and anxiety.No additional information was provided.
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