BEUDAMED
    FDA Adverse Event Other Summary report: N

    ICY HOT HEAT THERAPY PATCH

    MDR report key: 1002929 · Received February 8, 2008

    Report

    Report Number
    1022556-2008-00037
    Event Type
    Other
    Date Received
    February 8, 2008
    Report Date
    January 18, 2008
    Manufacturer
    CHATTEM, INC.
    Product Code
    IMD
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    SINCE THIS IS A DISPOSABLE SINGLE-USE DEVICE, THE PATCH IS UNAVAILABLE FOR EVAL AND ANALYSIS. REVIEW CONDUCTED BY MFR YIELDED NO SIGNIFICANT COMPLAINTS OR TRENDS REGARDING THIS LOT NUMBER. WE WILL CONTINUE TO MONITOR FOR OTHER SIMILAR COMPLAINTS, COMPOSE TREND REPORTS AND UTILIZE THE INFO FOR CONTINUOUS IMPROVEMENT. 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 USED THE PRODUCT ON HER HIP AND KNEE FOR SEVEN TO EIGHT HOURS TO TREAT ARTHRITIS PAIN. WHEN SHE REMOVED THE PATCHES, SHE HAD BURNS AND BLISTERS IN THE AREA. THE CONSUMER USED PRESCRIPTIONS FOR AVELOX AND MUPIROCIN TO PREVENT INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ICY HOT HEAT THERAPY PATCH IMD CHATTEM, INC. 083 2A706

    Patients

    Seq Age Sex Outcome Treatment
    1 THYROID AND BLOOD PRESSURE MEDICATIONS AS WELL AS| NEXIUM AND EMBREL AT THE TIME OF INCIDENT| THE CONSUMER WAS TAKING UNSPECIFIED ARTHRITIS