BEUDAMED
    FDA Adverse Event Other Summary report: N

    ICY HOT HEAT THERAPY PATCH

    MDR report key: 1013211 · Received March 12, 2008

    Report

    Report Number
    1022556-2008-00164
    Event Type
    Other
    Date Received
    March 12, 2008
    Date of Event
    November 24, 2007
    Report Date
    February 12, 2008
    Manufacturer
    CHATTEM, INC.
    Product Code
    IMD
    Removal / Correction Number
    NA AT THIS TIME
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    SINCE THIS A DISPOSABLE SINGLE-USE DEVICE, THE PATCH IS UNAVAILABLE FOR EVALUATION AND ANALYSIS. THIS REPORT IS BELOW THE THRESHOLD OF THE FDA'S REQUIREMENTS FOR MANDATORY REPORTING OF ADVERSE EVENTS INVOLVING MEDICAL DEVICES, AS THERE IS NO EVIDENCE THAT USE OF THE PRODUCT RESULTED IN SERIOUS ADVERSE HEALTH CONSEQUENCES. INSTEAD, OUR INVESTIGATION HAS DETERMINED THAT THE PATIENT EXPERIENCED TEMPORARY OR MEDICALLY REVERSIBLE ADVERSE HEALTH CONSEQUENCES. ACCORDINGLY, THIS MDR IS BEING SUBMITTED AS A VOLUNTARY AND PROACTIVE MEASURE BY THE MANUFACTURER TO ENHANCE PRODUCT SAFETY AND PHARMACOVIGILANCE.

    Description of Event or Problem · 1

    THE CONSUMER REPORTED, HER MOTHER USED THE PRODUCT FOR SEVEN TO EIGHT HOURS ON HER LEFT SHOULDER AREA. WHEN THE PATCH WAS REMOVED, THE CONSUMER DESCRIBED SKIN REMOVAL AND A BURN IN THE AREA WORN. THE CONSUMER'S MOTHER WAS IN A NURSING FACILITY AT THE TIME OF THE INCIDENT AND RECEIVED MEDICAL ATTENTION WHICH INCLUDE ORAL ANTIBIOTICS AND ANTIBIOTIC SALVE TO TREAT THE AREA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ICY HOT HEAT THERAPY PATCH IMD CHATTEM, INC. 083 3A6ZC

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR NEXIUM| BLOOD PRESSURE MEDICATION| LEXAPRO| DEPAKOTE