(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.Mwr-(b)(4) submitted for adverse event which occurred on (b)(6) 2017.Mwr-(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 ventral/incisional hernia repair surgery on (b)(6) 2017 and mesh was implanted.It was reported that the patient underwent recurrent incisional hernia repair surgery on 5/13/2019 during which the surgeon noted the previously placed mesh which he noted to have a hoe.The hernia was noted to be coming through the mesh where the hole was located.It was reported that the patient experienced severe pain, adhesions, scarring, nausea, diarrhea, chills, inflammation and loss of appetite.Other procedures are captured in a separate file.No additional information is provided.
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