BEUDAMED
    FDA Adverse Event Other Summary report: N

    ICY HOT HEAT THERAPY

    MDR report key: 1014168 · Received March 13, 2008

    Report

    Report Number
    1022556-2008-00262
    Event Type
    Other
    Date Received
    March 13, 2008
    Report Date
    September 29, 2007
    Manufacturer
    CHATTEM, INC.
    Product Code
    IMD
    Removal / Correction Number
    Z-1196-2008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    SINCE THIS IS 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 PT EXPERIENCED TEMPORARY OR MEDICALLY REVERSIBLE ADVERSE HEALTH CONSEQUENCES. ACCORDINGLY, THIS MDR IS BEING SUBMITTED AS A VOLUNTARY AND PROACTIVE MEASURE BY THE MFR TO ENHANCE PRODUCT SAFETY AND PHARMACOVIGILANCE.

    Description of Event or Problem · 1

    THE CONSUMER REPORTED, USING THE PRODUCT FOR SEVEN HOURS ON HER LOWER BACK. WHEN THE PATCH WAS REMOVED, THE CONSUMER DESCRIBED SKIN REMOVAL WHICH TOOK TWO-WEEKS TO HEAL AND LEFT A SLIGHT SCAR. THE CONSUMER DID NOT SEEK MEDICAL ATTENTION AT THE TIME OF THE INCIDENT AND SELF-MEDICATED THE AREA AT HOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ICY HOT HEAT THERAPY IMD CHATTEM, INC. 083 3A7O9

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR