BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TVT EXACT SLING

    MDR report key: 11207437 · Received January 20, 2021

    Report

    Report Number
    MW5098912
    Event Type
    Malfunction
    Date Received
    January 20, 2021
    Date of Event
    June 30, 2020
    Report Date
    January 15, 2021
    Manufacturer
    ETHICON, INC.
    Product Code
    PWJ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    TVT EXACT SLING INSERTION DEVICE MALFUNCTION. SLING INSERTION DEVICE BROKE THE WHITE PART OF THE SLING. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    101829 TVT EXACT SLING INSTRUMENTATION, SURGICAL MESH, UROGYNECOLOGIC, STRESS URINARY INCONTINENCE PWJ ETHICON, INC. 3935297

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR