(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) was created in error as this event will now be converted to emdr. all information will be submitted via 3500a emdr mwr-11122018-0000272286.
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It was reported by an attorney that the patient underwent a gynecological surgical procedure on (b)(6) 2004 and mesh was implanted.It was reported that the patient underwent a gynecological surgical procedure on (b)(6) 2007 and mesh was implanted.It was reported that the patient underwent a removal surgery on (b)(6) 2014 and mesh was implanted.It was reported that she experienced pain, erosion of her internal bodily tissue and other injuries following the procedure.It was reported that following the procedure the patient experienced blood in urine, stress incontinence, bleeding from vaginal area, rectocele, prolapse vaginal walls, and female pelvic pain.It was reported that the patient has undergone multiple surgeries and revisionary procedures.No additional information was provided.
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