BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ICY HOT HEAT THERAPY BACK PATCH

    MDR report key: 1003371 · Received February 24, 2008

    Report

    Report Number
    MW5005655
    Event Type
    Injury
    Date Received
    February 24, 2008
    Date of Event
    January 18, 2008
    Report Date
    February 24, 2008
    Manufacturer
    CHATTEM, INC
    Product Code
    IMD
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IL, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    BURNING CAUSED BY USING ICY HOT HEAT THERAPY BACK PATCH. SMALL AREA OF SKIN APPROX 1/2" TORN OFF WHEN REMOVING PATCH TREATED WITH ANTIBIOTIC OINTMENT & COVERED WITH GAUZE. HEALED AFTER ABOUT 7 DAYS, SMALL RED MARK LEFT. DATES OF USE: 2008. DIAGNOSIS OR REASON FOR USE: LUMBAR PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ICY HOT HEAT THERAPY BACK PATCH NONE IMD CHATTEM, INC 3A7SE

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR