This event was previously reported to the fda on an alternative summary report (asr approval #: (b)(4)) which is no longer in effect.Because of additionally received complaint information, this and all further updates will be submitted through the 3500a form.(b)(4).If information is provided in the future, a supplemental report will be issued.
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The patient¿s attorney alleged a deficiency against the device.The product was used for therapeutic treatment of vaginal wall prolapse and stress urinary incontinence.It was reported that after implant, the patient experienced right medial thigh pain, pain shooting into vagina, paresthesia with numbness, voiding difficulty, pelvic pain, pelvic plexopathy, clinical weakness involving both lower limbs, urge and stress urinary incontinence, vaginismus, dyspareunia, and stage ii rectocele.Post-operative patient treatment included rectocele repair, sling removal, enterocele repair, cystoscopy.
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