BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ICY HOT HEAT THERAPY AIR

    MDR report key: 1013091 · Received March 11, 2008

    Report

    Report Number
    MW5005862
    Event Type
    Injury
    Date Received
    March 11, 2008
    Date of Event
    March 10, 2008
    Report Date
    March 11, 2008
    Manufacturer
    CHATTEM, INC
    Product Code
    IMD
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I APPLIED AN "ICY HOT HEAT THERAPY AIR ACTIVATED HEAT PATCH" TO MY LOWER BACK YESTERDAY MORNING. WHEN I TRIED TO REMOVE THE PATCH THAT AFTERNOON, A 2" X 1 1/2" PATCH OF SKIN CAME OFF WITH IT. MY PHYSICIAN DIAGNOSED A SECOND DEGREE BURN WHICH REQUIRED PRESCRIPTION MEDICAL TREATMENT. DATES OF USE: 2008, 8 HOURS . DIAGNOSIS OR REASON FOR USE: STAY WARM ON GOLF COURSE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Other