BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN

    MDR report key: 2820799 · Received October 30, 2012

    Report

    Report Number
    MW5027419
    Event Type
    Malfunction
    Date Received
    October 30, 2012
    Date of Event
    October 4, 2012
    Report Date
    October 30, 2012
    Manufacturer
    UNK
    Product Code
    FTL
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    (B)(6) PRESENTED 3 OR 4 YEARS BUT FROM A SLING PROCEDURE. SHE HAS HAD PERSISTENT PROBLEMS WITH RECURRENT INFECTIONS, VAGINAL PAIN, AND URGE INCONTINENCE AND INSENSIBLE INCONTINENCE. SHE REQUESTED ELECTIVE TREATMENT OF THE SAME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN BLADDER SLING FTL UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Other