BEUDAMED
    FDA Adverse Event Other Summary report: N

    ICY HOT HEAT THERAPY

    MDR report key: 1002024 · Received February 20, 2008

    Report

    Report Number
    MW5005617
    Event Type
    Other
    Date Received
    February 20, 2008
    Date of Event
    February 12, 2008
    Report Date
    February 20, 2008
    Manufacturer
    CHATTEM, INC
    Product Code
    IMD
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    AK, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    ICY HOT AIR ACTIVATED HEAT PATCH CAUSED BLISTERS ON MY BACK WHICH RESULTED IN CONSIDERABLE PAIN AND SCARRING. DATES OF USE: 2008. DIAGNOSIS OR REASON FOR USE: BACK PAIN. EVENT ABATED AFTER USE STOPPED OR DOSE REDUCED? YES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ICY HOT HEAT THERAPY NONE IMD CHATTEM, INC * 3A7SI

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Other