BEUDAMED
    FDA Adverse Event Other Summary report: N

    ICY HOT HEAT THERAPY PATCH

    MDR report key: 931247 · Received October 18, 2007

    Report

    Report Number
    1022556-2007-00252
    Event Type
    Other
    Date Received
    October 18, 2007
    Date of Event
    May 1, 2007
    Report Date
    September 19, 2007
    Manufacturer
    CHATTEM INC.
    Product Code
    IMD
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    CONSUMER USED PRODUCT ON HER LOWER BACK IN 2007 AND LEFT IT ON FOR 5-6 HOURS. PRODUCT CAUSED THREE 2ND DEGREE BURNS ON BACK. AFTER 4 DAYS WENT TO HER DOCTOR FOR TREATMENT. SHE HAS SEEN DOCTOR 3 ADDITIONAL TIMES OVER SIX WEEKS WHILE BURN WAS HEALING. PRODUCT WAS INITIALLY IDENTIFIED INCORRECTLY BY CONSUMER AS AN OTC MEDICATED PATCH. INCIDENT 093469.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ICY HOT HEAT THERAPY PATCH IMD CHATTEM INC. 083

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR TYLENOL| PROZAC| UNSPECIFIED VITAMINS TAKEN DAILY