BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ICY HOT HEAT THERAPY

    MDR report key: 1000329 · Received February 18, 2008

    Report

    Report Number
    MW5005546
    Event Type
    Malfunction
    Date Received
    February 18, 2008
    Date of Event
    February 15, 2008
    Report Date
    February 18, 2008
    Manufacturer
    CHATTEM
    Product Code
    IMD
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    ICY HOT HEAT THERAPY AIR ACTIVATED HEAT PATCH APPLIED TO LOWER BACK WHEN REMOVED CAUSED BURN AREA WITH REDNESS AND LOSS OF SKIN IN PLACES WITH BLISTERS PAIN AND STINGING IN APPROX 2X2IN AREA. DOSE OR AMOUNT: ONE PATCH FOR 8 HOUR RELIEF, FREQUENCY: ONCE IN 24 HOUR, ROUTE: TOP. DATES OF USE: 2008. DIAGNOSIS OR REASON FOR USE: BACK PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ICY HOT HEAT THERAPY NONE IMD CHATTEM 3A7TS

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Other