(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.Psr-66077 submitted for adverse event which occurred on (b)(6) 2014.Mwr-17072020-0000767785 submitted for adverse event which occurred on (b)(6) 2014.Mwr-17072020-0000767786 submitted for adverse event which occurred on (b)(6) 2015.Mwr-17072020-0000767791 submitted for adverse event which occurred on (b)(6) 2015.Mwr-17072020-0000767794 submitted for adverse event which occurred on (b)(6) 2016.Mwr-17072020-0000767796 submitted for adverse event which occurred on unknown date.
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It was reported by an attorney that the patient underwent a gynecological surgical procedure on (b)(6) 2010 and mesh was implanted, due to stress urinary incontinence.It was reported that the patient underwent a vaginal hysterectomy; bilateral salpingooophorectomy and placement of mesh on (b)(6) 2014.It was reported that the patient experienced a vaginal mass on (b)(6) 2014 and underwent excision and removal of the mass and over-sew of vaginal cuff defect with electrocautery of granulation tissue site.It was reported that the patient underwent mesh removal surgery and cystoscopy on (b)(6) 2015.It was reported that the patient underwent urethral bulking with macroplastique on (b)(6) 2015.It was reported that the patient underwent urethrolysis, suburethral sling removal and right paravaginal defect repair on (b)(6) 2016.It was reported that the patient underwent pudendal nerve blocks on (b)(6) 2016, on (b)(6) 2016, on (b)(6) 2016, on (b)(6) 2017 and on (b)(6) 2017.It was reported that the patient underwent colpopexy, paravaginal repair pudenal nerve black and placement of retrobupubic sling, due to her 3rd degree cystocele and 90 degree rotation of her urethra.No additional information was provided.
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