BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GYNECARE TVT SLING

    MDR report key: 1983678 · Received February 6, 2011

    Report

    Report Number
    MW5019329
    Event Type
    Injury
    Date Received
    February 6, 2011
    Date of Event
    June 18, 2004
    Report Date
    February 6, 2011
    Manufacturer
    ETHICON
    Product Code
    FTL
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    AZ, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    PELVIC INFECTION, EROSION OF MESH, INFLAMMATION, NERVE DAMAGE, MIGRATION, AUTOIMMUNE DISEASE DEVELOPMENT, MULTIPLE SURGERIES TO REMOVE MESH. EVENT DID NOT ABATE AFTER USE STOPPED. DIAGNOSIS OR REASON FOR USE: PELVIC ORGAN PROLAPSE. A SECOND IMPLANT SURGERY ON (B)(6) 2008 IN WHICH APOGEE STEM WITH INTEPRO LITE REF #720002-01, LOT#525271007 EXP 2008, NOV 5, BY AMERICAN MEDICAL SYSTEMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GYNECARE TVT SLING TRANSVAGINAL MESH OR SLING FTL ETHICON 1189156
    2 PROLENE MESH TRANSVAGINAL MESH OR SLING FTL ETHICON TCB139
    3 APOGEE STEM WITH INTEPRO LITE TRANSVAGINAL MESH OR SLING FTL AMERICAN MEDICAL SYSTEMS 525271007

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Hospitalization| L| O| R| S