BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GYNECARE TVTO

    MDR report key: 4251859 · Received October 10, 2014

    Report

    Report Number
    4251859
    Event Type
    Malfunction
    Date Received
    October 10, 2014
    Date of Event
    June 18, 2014
    Report Date
    October 10, 2014
    Manufacturer
    ETHICON, INC.
    Product Code
    OTN
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US

    Narratives

    Description of Event or Problem · 1

    PATIENT IS AN ELDERLY WOMAN WHO HAD A RECTOCELE AND A SLING PROCEDURE DONE ABOUT 4 YEARS AGO; SINCE THAT TIME, HAS HAD RECURRENT URINARY TRACT INFECTIONS AS WELL AS URINARY INCONTINENCE, URGE TYPE. SHE ALSO HAS HESITANCY, DIFFICULTY INITIATING VOIDING, STRAINING AND PUSHING TO URINATE, AND URODYNAMICS HAVE PROVEN BLADDER OUTLET OBSTRUCTION. IT WAS NOT PLANNED TO REMOVE THE ENTIRE SLING SINCE IT HAD BEEN EFFECTIVE FOR STRESS INCONTINENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    643148 GYNECARE TVTO MESH, SURGICAL, GYNECOLOGIC OTN ETHICON, INC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR