BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ADVANTAGE TRANSVAGINAL MID-URETHRAL SLING SYSTEM

    MDR report key: 8541164 · Received April 22, 2019

    Report

    Report Number
    MW5086067
    Event Type
    Injury
    Date Received
    April 22, 2019
    Date of Event
    August 13, 2014
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    FTL
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    AZ, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I WAS DIAGNOSED WITH CENTRAL SENSITIVITY SYNDROME, INCLUDING FIBROMYALGIA AND CHRONIC FATIGUE SYNDROME THAT I BELIEVE IS DIRECTLY RELATED TO THE DEVICE. THE DEVICE HAS PENETRATED THE VAGINAL WALL AD CAUSES PAIN AND BLEEDING. VAGINAL PROLAPSE IS NOW AT 50%. THERE IS ONLY ONE DR IN (B)(6) QUALIFIED TO REMOVE THE DEVICE IN ITS ENTIRETY AND HE IS LOCATED IN (B)(6). I AM CURRENTLY TRYING TO GET AN APPT. OTHER (B)(6) DRS ARE NOT COMFORTABLE REMOVING THE ENTIRE DEVICE, NOR ARE THEY QUALIFIED. MY HEALTH HAS BEEN FAILING SINCE THE DEVICE WAS PLACED DURING A HYSTERECTOMY ON (B)(6) 2007 AT (B)(6) CLINIC). FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    331524 ADVANTAGE TRANSVAGINAL MID-URETHRAL SLING SYSTEM MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE FTL BOSTON SCIENTIFIC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Required Intervention| S