BEUDAMED
    FDA Adverse Event Other Summary report: N

    ICY HOT HEAT THERAPY PATCH

    MDR report key: 1033683 · Received April 22, 2008

    Report

    Report Number
    1022556-2008-00503
    Event Type
    Other
    Date Received
    April 22, 2008
    Date of Event
    February 24, 2008
    Report Date
    March 31, 2008
    Manufacturer
    CHATTEM, INC.
    Product Code
    IMD
    Removal / Correction Number
    Z-1197-2008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, 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 FOR 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 FOUR HOURS ON HER UPPER RIGHT AND LEFT HIPS. WHEN THE PATCHES WERE REMOVED, THE CONSUMER DESCRIBED THIRD DEGREE BURNS AND SKIN REMOVAL IN THE AREAS WORN. THE CONSUMER SOUGHT MEDICAL ATTENTION AND TREATMENT OF HER INJURIES WHICH INCLUDED A HOSPITAL STAY FOR SURGICAL DEBRIDEMENT, BURN CARE (SILVER SULFADIAZINE AND DRESSING CHANGES) AND PAIN MANAGEMENT (MORPHINE AND LORTAB).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ICY HOT HEAT THERAPY PATCH IMD IMD CHATTEM, INC. 083 2A7Q9

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR THE CONSUMER REPORTED TAKING ARTHRITIS MEDICATION| AT THE TIME OF THE INCIDENT.