BEUDAMED
    FDA Adverse Event Other Summary report: N

    ANCHOR FIX MULTI-PURPOSE COVER TAPE

    MDR report key: 604921 · Received May 19, 2005

    Report

    Report Number
    2939821-2005-00001
    Event Type
    Other
    Date Received
    May 19, 2005
    Date of Event
    May 5, 2005
    Report Date
    May 12, 2005
    Manufacturer
    NORTH COAST MEDICAL, INC.
    Product Code
    KGX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICAL THERAPIST

    Narratives

    Description of Event or Problem · 1

    AFTER RECEIVING TREATMENT TO ALTER PATELLAR (KNEECAP) POSITIONING, PT EXPERIENCED SKIN LOSS WHEN ANCHOR FIX UNDERWRAP (ADHESIVE FABRIC TAPE) WAS REMOVED. PHYSICIAL THERAPIST NOTICED SIGNIFICAN SKIN LOSS, LEAVING A 4CM DIAMETER WOUND ON THE MEDIAN AND LATERAL SIDE OF BOTH KNEES. THE WOUND WAS WEEPING AND LOOKED ALMOST LIKE A CHEMICAL BURN. PT TREATED FOR IRRITATION AND SKIN LOSS BY A NURSE ELSEWHERE. UPON EXAMINATION BY THE PHYSICAL THERAPIST, IT WAS DETERMINED THAT WOUND WASN'T SOMETHING THAT NEEDED TO BE TREATED. ANCHOR FIX UNDERWRAP WAS LEFT ON FOR 1 1/2 DAYS. PATIENT HAS REMOVED UNDERWRAP PERSONNALLY. PATIENT WAS SEEN BY TWO PHYSISCAL THERAPIST. "PHYSICAL THERAPIST NOTICED THAT THE FIRST FEW LAYERS OF EPIDERMIS WAS REMOVED, LEAVING A 3" X 2" LAYERS OF EPIDERMIS WAS REMOVED, LEAVING A 3" X 2" WOUND ON THE LATERAL SIDE OF BOTH KNEES. PT WAS TOLD TO LEAVE ANCHOR FIX UNDERWRAP ON DURING DAY AND TAKE OFF IN THE EVENING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANCHOR FIX MULTI-PURPOSE COVER TAPE ADHESIVE FABRIC TAPE (UNDERWRAP) KGX NORTH COAST MEDICAL, INC. NC22001-2 A0416

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Other