BEUDAMED
    FDA Adverse Event Other Summary report: N

    ICY HOT HEAT THERAPY PATCH

    MDR report key: 1071435 · Received July 2, 2008

    Report

    Report Number
    1022556-2008-00579
    Event Type
    Other
    Date Received
    July 2, 2008
    Report Date
    June 13, 2008
    Manufacturer
    CHATTEM, INC.
    Product Code
    IMD
    Removal / Correction Number
    Z-1196-2008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE CONSUMER USED THE PRODUCT OFF-LABEL BY WEARING THE PATCH WHILE SLEEPING. SINCE THIS IS A DISPOSABLE SINGLE-USE DEVICE, THE PATCH IS UNAVAILABLE FOR EVAL 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 MANUFACTURER TO ENHANCE PRODUCT SAFETY AND PHARMACOVIGILANCE.

    Description of Event or Problem · 1

    THE CONSUMER'S HUSBAND REPORTED, HIS WIFE USED THE PRODUCT FOR EIGHT HOURS WHILE SLEEPING. WHEN THE PATCH WAS REMOVED, THE CONSUMER DESCRIBED BURNS IN TWO AREAS. THE CONSUMER WENT TO THE EMERGENCY ROOM AND WAS PRESCRIBED SILVER SULFADIAZINE. THE CONSUMER ALSO CONSULTED WITH HER FAMILY DOCTOR. NO FURTHER DETAIL PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ICY HOT HEAT THERAPY PATCH IMD CHATTEM, INC. 083 3A6YI

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR UNSPECIFIED BLOOD PRESSURE MEDICATION| CHOLESTEROL MEDICATIONS| REQUIP