BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ICY HOT MEDICATED PATCH EXTRA STRENGTH

    MDR report key: 1047068 · Received May 17, 2008

    Report

    Report Number
    MW5006882
    Event Type
    Injury
    Date Received
    May 17, 2008
    Date of Event
    May 3, 2008
    Report Date
    May 17, 2008
    Manufacturer
    CHATTEM
    Product Code
    IMD
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MN, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I PURCHASED A WHITE BOX OF "EXTRA STRENGTH ICY HOT MEDICATED PATCHES" FOR THE BACK IN 2008. THE NUMBERS OR CODES ON THE BOX SAID EXP 09/10. THE FOLLOWING MONTH, I APPLIED, AS DIRECTED, THE PATCH ON MY LOWER BACK. WITHIN 10 MINUTES, I NOTICED MORE "HEAT" THAN USUAL. AT 45 MINUTES, I HAD TO FIND A RESTROOM TO REMOVE THE PATCH. I WAS FEELING BURNED, IN PAIN, MY SKIN WAS RED AND IRRITATED. I TOOK A PAPER TOWEL AND WITH SOAP AND WATER TO TRY AND REMOVE ANY CHEMICALS THAT MAY HAVE BEEN LEFT ON MY SKIN. I WAS IN PAIN FOR 2 1/2 TO 3 DAYS. MY SKIN DID NOT BLISTER, SO I DID NOT END UP SEEING A DOCTOR. I REALIZE THE ICY HOT RECALL WAS FOR THE RED POUCHED "AIR-ACTIVATED" ITEMS AND THE ITEM I USED WASN'T, BUT FELT I SHOULD REPORT THIS INCIDENT TO THE FDA AND THE MAKERS OF THE ICY HOT PATCHES. THANK YOU. DOSE OR AMOUNT: ONE BACK PATCH; FREQUENCY: ONCE; ROUTE: UNK. DATES OF USE: 2008 45 - 50 MINUTES. DIAGNOSIS OR REASON FOR USE: TEMPORARY RELIEF OF MINOR BACK PAIN. EVENT ABATED AFTER USE STOPPED OR DOSE REDUCED? NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ICY HOT MEDICATED PATCH EXTRA STRENGTH NONE IMD CHATTEM 1107

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Other