BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ICY HOT HEAT THERAPY

    MDR report key: 980095 · Received January 3, 2008

    Report

    Report Number
    MW5004974
    Event Type
    Injury
    Date Received
    January 3, 2008
    Date of Event
    September 20, 2007
    Report Date
    January 3, 2008
    Manufacturer
    CHATTEM INC.
    Product Code
    IMD
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I USED AN ICY HOT PATCH ON MY SHOULDER TO RELIEVE PAIN. THE PATCH WAS ON FOR SEVERAL HOURS. MY SHOULDER FELT LIKE IT WAS ON FIRE. WHEN I REMOVED THE PATCH SEVERAL LAYERS OF MY SKIN WERE ATTACHED. I SUFFERED A VERY PAINFUL BURN AND STILL HAVE A SCAR. MY SKIN IS PRETTY TOUGH AS COMPARED TO MOST. I AM CONCERNED ABOUT THE POTENTIAL BURNS TO ELDERLY, DIABETICS ETC WHO ARE NOT MADE AWARE OF THE POTENTIAL FOR INJURY. I CONTACTED CHATTEM INC. TO TELL THEM ABOUT THE PROBLEM AND SENT THEM PICTURES OF MY BURNS. DOSE OR AMOUNT: PATCH. DATES OF USE: 2007. EVENT ABATED AFTER USE STOPPED: NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ICY HOT HEAT THERAPY NONE IMD CHATTEM INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR