BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GYNCARE TVT EXACT

    MDR report key: 5297591 · Received December 15, 2015

    Report

    Report Number
    5297591
    Event Type
    Malfunction
    Date Received
    December 15, 2015
    Date of Event
    August 27, 2014
    Report Date
    November 12, 2015
    Manufacturer
    ETHICON, INC.
    Product Code
    PAH
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PREOPERATIVE DIAGNOSIS: VOIDING DYSFUNCTION FOLLOWING TVT MIDURETHRAL SLING. POSTOPERATIVE DIAGNOSIS: SAME. PROCEDURE: MIDURETHRAL SLING REVISION AND CYSTOURETHROSCOPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    827686 GYNCARE TVT EXACT MESH, SURGICAL, GYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, FEMALE PAH ETHICON, INC. 3749314

    Patients

    Seq Age Sex Outcome Treatment
    1 0 YR