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) 2012.(b)(4) submitted for adverse event which occurred on (b)(6) 2013.
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It was reported by an attorney that the patient underwent a gynecological surgical procedure on (b)(6) 2012 and mesh was implanted.It was reported that the patient underwent a gynecological surgical procedure on (b)(6) 2012 and two (2) mesh products were implanted.It was reported that the patient underwent a gynecological surgical procedure on (b)(6) 2013.It was reported that she experienced back pain, groin pain, stomach pain, pain in the vagina, vaginal thrush, urinary tract infections, severe and painful bowel movements, and sleep disturbance.Other procedure is captured under separate file.No additional information was provided.
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