BEUDAMED
    FDA Adverse Event Other Summary report: N

    ICY HOT HEAT THERAPY PATCH

    MDR report key: 1071436 · Received July 2, 2008

    Report

    Report Number
    1022556-2008-00578
    Event Type
    Other
    Date Received
    July 2, 2008
    Date of Event
    April 3, 2008
    Report Date
    June 11, 2008
    Manufacturer
    CHATTEM, INC.
    Product Code
    IMD
    Removal / Correction Number
    Z-1196-2008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, 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. 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 REPORTED USING THE PRODUCT ON HER STOMACH FOR SIX HOURS. WHEN THE PATCH WAS REMOVED, THE CONSUMER DESCRIBED SKIN REMOVAL WITH REDNESS, INFLAMMATION AND BURNING. THE CONSUMER INITIALLY DID NOT TREAT THE AREA. THE FOLLOWING DAY, SHE WENT TO THE HOSPITAL AND WAS DIAGNOSED WITH SECOND DEGREE BURNS WHICH WERE TREATED WITH UNSPECIFIED OINTMENT AND GAUZE. THE CONSUMER TOOK VICODIN AND IBUPROFEN TO RELIEVE SYMPTOMS AND THE AREA HAS SINCE HEALED WITH SUBSEQUENT SCARRING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ICY HOT HEAT THERAPY PATCH IMD CHATTEM, INC. 083 3A7RA

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR