BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    *

    MDR report key: 178837 · Received May 19, 1998

    Report

    Report Number
    MW4002298
    Event Type
    Malfunction
    Date Received
    May 19, 1998
    Report Date
    May 12, 1998
    Manufacturer
    AMERICAN WHITE CROSS, INC.
    Product Code
    KGX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE MFR OF THIS TAPE HAS CHANGED FROM A CLOTH TYPE WATERPROOF TAPE TO A PLASTIC TYPE WATERPROOF TAPE. PLASTIC TAPE DOES NOT MEET THE REQUIREMENTS FOR FOOT TAPING AS IT DOES NOT CONFORM TO THE SHAPE OF THE FOOT. FOOT TAPINGS ARE DONE ON A WEEKLY BASIS FOR ACUTE FLARE-UPS OF PLANTAR FASCIITIS AND HEEL SPURS SYNDROME. THIS PLASTIC TAPE LOSSES ITS ADHESIVENESS AFTER 1-2 DAYS. PTS HAVE COMPLAINED THAT THIS NEW TAPE IS UNCOMFORTABLE BECAUSE IT DOES NOT TAKE THE SHAPE OF THEIR FOOT AND IT WRINKLES CAUSING SORE SPOTS. THERE HAVE BEEN SEVERAL PTS WITH REGRESSION IN THEIR PROGRESS DUE TO THIS NEW TAPE. PLANTAR FASCIITIS AND HEEL SPUR SYNDROME ARE THE MOST COMMONLY SEEN PROBLEMS IN THE PODIATRY CLINIC AND TAPE IS USED EXTENSIVELY IN THE TREATMENT. DATE MFG: 11/96.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * SURGICAL ADHESIVE TAPE KGX AMERICAN WHITE CROSS, INC. NI 212850

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO