BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ICY HOT AIR ACTIVATED HEAT

    MDR report key: 1230127 · Received November 12, 2008

    Report

    Report Number
    MW5008978
    Event Type
    Injury
    Date Received
    November 12, 2008
    Date of Event
    November 6, 2008
    Report Date
    November 12, 2008
    Manufacturer
    CHATTEM
    Product Code
    IMD
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OH, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    ICY HOT HEAT THERAPY AIR ACTIVATED HEAT PATCH - USED AS DIRECTED - CAUSED STRIPS OF SKIN ON SHOULDER TO PEEL OFF, LEAVING VERY PAINFUL AREAS THAT ARE BEING SLOW TO HEAL. STILL PAINFUL. DATES OF USE: 6 HOURS IN 2008. DIAGNOSIS OR REASON FOR USE: MUSCLE PAIN. DOSE OR AMOUNT: FREQUENCY: ROUTE: TOP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ICY HOT AIR ACTIVATED HEAT 3.9" X 5.3" IMD CHATTEM 2A6ZD

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Other