BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TVT

    MDR report key: 1944544 · Received December 17, 2010

    Report

    Report Number
    1944544
    Event Type
    Malfunction
    Date Received
    December 17, 2010
    Date of Event
    December 9, 2010
    Report Date
    December 10, 2010
    Manufacturer
    ETHICON
    Product Code
    FTL
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    TWO DEVICES FAULTED DURING SURGICAL PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TVT VAGINAL TAPE FTL ETHICON 810041B 3447235

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR