BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VARIHESIVE E

    MDR report key: 84571 · Received April 16, 1997

    Report

    Report Number
    1049092-1997-00002
    Event Type
    Injury
    Date Received
    April 16, 1997
    Date of Event
    March 25, 1997
    Report Date
    April 4, 1997
    Manufacturer
    CONVATEC, A BRISTOL-MYERS SQUIBB CO.
    Product Code
    MGQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    A SIXTY YR OLD FEMALE PT PRESENTED WITH A LARGE LEG ULCER. DRESSED WITH DEVICE AND TREATED IN PARALLEL WITH HIGH-DOSE OZONE THERAPY. AFTER 1 DAY LEAKAGE AND HEAVY SENSITATION REACTION UNDER THE HYDROCOLLOID MASS. SURROUNDING SKIN WAS FIERY RED AND SWOLLEN AND ITCHING. OPINION OF THE TREATING PHYSICIAN WAS THAT THE OZONE THERAPY MAY HAVE ENHANCED THE SENSITIZATION REACTION. TREATMENT WITH STEROIDS AND CLEMATSIN (TAVEGIL) FOR TWO WEEKS UNTIL RESOLVED. PT HAD PROLONGED HOSPITALIZATION FOR ONE WEEK. SENSITIZATION REACTIONS ARE NOT UNKNOWN WITH THESE TYPES OF DRESSINGS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VARIHESIVE E HYDROCOLLOID WOUND DRESSING MGQ CONVATEC, A BRISTOL-MYERS SQUIBB CO. * 96 087 287

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Hospitalization| O OZONE THERAPY (STOP'D)