BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ICY HOT HEAT THERAPY PATCH - BACK

    MDR report key: 1002021 · Received February 21, 2008

    Report

    Report Number
    MW5005614
    Event Type
    Injury
    Date Received
    February 21, 2008
    Date of Event
    January 29, 2008
    Report Date
    February 10, 2008
    Manufacturer
    CHATTEM, INC.
    Product Code
    IMD
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    VA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    USED THE ICY HOT HEAT THERAPY PATCH ON UPPER BACK FOR PAIN. AFTER EIGHT HRS, THE AREA UNDER THE PATCH WAS BRIGHT RED AND BLISTERED IN ONE AREA (3 BLISTERS). "PICTURE OF BURNS ENCLOSED". SEE SCANNED PAGE. DOSE OR AMOUNT: 1 PATCH, FREQUENCY: 8 EIGHTS, ROUTE: PATCH. DATES OF USE: 2008. DIAGNOSIS: BACK PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ICY HOT HEAT THERAPY PATCH - BACK NONE IMD CHATTEM, INC. 3A7RS

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Other