BEUDAMED
    FDA Adverse Event Other Summary report: N

    ICY HOT HEAT THERAPY PATCH

    MDR report key: 884935 · Received July 24, 2007

    Report

    Report Number
    1022556-2007-00199
    Event Type
    Other
    Date Received
    July 24, 2007
    Date of Event
    June 24, 2007
    Report Date
    June 25, 2007
    Manufacturer
    CHATTEM, INC.
    Product Code
    IMD
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    REPORTER APPLIED PRODUCT TO SON'S THIGH THE PREVIOUS EVENING AND WHEN SHE REMOVED PATCH IN MORNING, PIECES OF SKIN CAME OFF WITH THE PATCH. HE WORE PATCH APPROXIMATELY 9 HOURS. SKIN ON LEG IS BUBBLY/BLISTERY LOOKING. SHE APPLIED POLYSPORIN OINTMENT TO AFFECTED AREA, THEY EMU OLL AND WRAPPED WITH GAUZE. SHE GAVE SON 1 ADVIL TABLET FOR PAIN AND SENT HIM TO SCHOOL. AFTER SCHOOL, THE GAUZE STUCK TO SKIN WHEN SHE TRIED TO REMOVE IT. SHE FEELS THAT THE CHILDS PROBLEM IS DUE TO THE ADHESIVE PULLING ON HIS SKIN. THE CHILD IS NOT BURNED AND THE PRODUCT NEVER HEATED UP. THE ADHESIVE WAS STRONG AND TORE OFF SKIN WHEN REMOVED AND LEFT SKIN WITH BURN AREA. MOTHER CALLED PEDIATRICIAN AND HE ADVISED TO CONTINUE USING NEOSPORIN AND WATCH FOR INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ICY HOT HEAT THERAPY PATCH IMD CHATTEM, INC. 083 A6XR

    Patients

    Seq Age Sex Outcome Treatment
    1 11 YR