BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENSION FREE VAGINAL TAPE

    MDR report key: 557762 · Received December 3, 2004

    Report

    Report Number
    2210968-2004-00597
    Event Type
    Injury
    Date Received
    December 3, 2004
    Date of Event
    January 1, 2004
    Report Date
    November 5, 2004
    Manufacturer
    ETHICON, INC.
    Product Code
    FTL
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNEVENTFUL SLING PROCEDURE IN 2004. AT THE 6 WEEK POST-OP CHECK UP THE PATIENT PRESENTED WITH SOME NEUROLOGIC SYMPTOMS, SPECIFICALLY LEFT LATERAL CALF NUMBNESS, LEFT FOOT NUMBNESS AND POSTERIOR THIGH NUMBNESS AND PAIN AT TIMES-INTERMITTENTLY. PATIENT HAS SEEN A PHYSIATRIST WHO TOLD PT IT MIGHT TAKE 6-12 MONTHS TO IMPROVE. PATIENT WAS PRESCRIBED TOPOMAX 50 MG PO QHS, WHICH SEEMED TO CONTROL THEIR SYMPTOMS. THE TOPOMAX WAS RECENTLY INCREASED TO 75 MG DUE TO BREAKTHROUGH PAIN AT THE 50 MG DOSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TENSION FREE VAGINAL TAPE MESH,SURGICAL, POLYMERIC FTL ETHICON, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Disability