BEUDAMED
    FDA Adverse Event Other Summary report: N

    ICY HOT HEAT THERAPY PATCH

    MDR report key: 1014174 · Received March 13, 2008

    Report

    Report Number
    1022556-2008-00255
    Event Type
    Other
    Date Received
    March 13, 2008
    Date of Event
    February 5, 2008
    Report Date
    February 15, 2008
    Manufacturer
    CHATTEM, INC.
    Product Code
    IMD
    Removal / Correction Number
    Z-1196-2008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE CONSUMER USED THE PRODUCT OFF-LABEL BY WEARING WHILE SLEEPING. 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 HER HUSBAND USED THE PRODUCT FOR SIX HOURS ON HIS UPPER LEG WHILE SLEEPING. WHEN THE PATCH WAS REMOVED, THE CONSUMER DESCRIBED TWO RED WELTS WITH PUS AND BLOOD FROM AN APPARENT BURN. THE CONSUMER CONSULTED WITH HIS PHARMACIST AND TREATED THE AREA WITH DIFFERENT ANTIBIOTICS AND CREAMS, SUCH AS TRIPLE ANTIBIOTIC OINTMENT AND ALOE VERA.

    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 74 YR COUMADIN| OTHER PRESCRIPTION MEDICATIONS