BEUDAMED
    FDA Adverse Event Other Summary report: N

    ICY HOT PATCH

    MDR report key: 1000327 · Received February 18, 2008

    Report

    Report Number
    MW5005544
    Event Type
    Other
    Date Received
    February 18, 2008
    Date of Event
    February 16, 2008
    Report Date
    February 18, 2008
    Manufacturer
    CHATTEM, INC.
    Product Code
    IMD
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    AFTER USING THE ICY HOT MEDICATED BACK PATCH FOR 2 DAYS, I HAD MULTIPLE RASH/SKIN IRRITATIONS ALL OVER MY BACK AND FRONT CHEST. WHERE THE PATCH WAS LOCATED WAS A FIRST DEGREE BURN AND THE OTHER SKIN IRRITATIONS LOOK AS IF THEY ARE THE RESULT OF HEAT RASH. THE IRRITATIONS ARE VERY ITCHY AND THE AREA WHERE THE PATCH WAS PALCED IS VERY SENSITIVE TO TOUCH. EXTRA STRENGTH ICY HOT PATCH - BACK USED THREE DAYS IN 2008. DOSE OR AMOUNT: 2 PATCHES, FREQUENCY: ONCE A DAY, ROUTE: TOP. DATES OF USE: 2008. DIAGNOSIS OR REASON FOR USE: BACK MUSCLE STRAIN. EVENT ABATED AFTER USE STOPPED OR DOSE REDUCED? YES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ICY HOT PATCH ICY HOT IMD CHATTEM, INC. 0044797-01

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR Other