BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ICY HOT PATCH

    MDR report key: 1052879 · Received May 27, 2008

    Report

    Report Number
    MW5007041
    Event Type
    Malfunction
    Date Received
    May 27, 2008
    Date of Event
    May 26, 2008
    Report Date
    May 27, 2008
    Manufacturer
    CHATTEM, INC.
    Product Code
    IMD
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    PURCHASED A PACKAGE OF 5-ICY HOT PATCHES AT STORE, BECAUSE I WAS HAVING MUSCLE DISCOMFORT IN MY LEFT UPPER ARM. THE PATCH WAS APPLIED IN 2008. WHEN TRYING TO REMOVE THE PATCH, IT WOULD NOT COME OFF AND WAS VERY PAINFUL, I HAD MY BOYFRIEND TRY TO TAKE IT OFF AND THE RESULT WAS BURNED SKIN ON THE TOP AND BURNED BRUISED SKIN UNDERNEATH. I HAVE TAKEN PICTURES WHICH SHOW THE BURNS. TO MY SURPRISE, WHEN I WENT ON LINE TO THE CHATTEM WEBSITE TO REPORT THIS INCIDENT, I SAW THAT THERE WAS A RECALL FOR SOME ICY HOT PRODUCTS WHICH WERE CAUSING BURNS. WHILE I AM NOT SURE IF THIS IS ONE OF THE PRODUCTS LISTED, I WAS SHOCKED TO SEE THAT THE RECALL SAID THE PRODUCTS WERE CAUSING BURNS. I AM CONTACTING CHATTEM TOMORROW AS IT STATES TO DO SO ON THEIR WEBSITE AS WELL AS CONTACT FDA. DOSE OR AMOUNT: ONE PATCH. FREQUENCY: ONCE. ROUTE: TOP. DATES OF USE: TWO DAYS IN 2008. DIAGNOSIS OR REASON FOR USE: MUSCLE PAIN IN UPPER ARM. EVENT ABATED AFTER USE STOPPED: NO.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Other