BEUDAMED
    FDA Adverse Event Other Summary report: N

    ICY HOT HEAT THERAPY PATCH

    MDR report key: 1003030 · Received February 11, 2008

    Report

    Report Number
    1022556-2008-00053
    Event Type
    Other
    Date Received
    February 11, 2008
    Date of Event
    June 1, 2007
    Report Date
    June 5, 2007
    Manufacturer
    CHATTEM, INC.
    Product Code
    IMD
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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. THE UNUSED PORTION OF THE PRODUCT HAS BEEN RETURNED TO THE MFR. 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 USING THE PRODUCT FOR SIX AND A HALF HOURS ON HER LOWER BACK. WHEN THE PATCH WAS REMOVED, THERE WAS A BURN AND SKIN REMOVAL RESULTING IN A SHALLOW ULCER WITH SURROUNDING ERYTHEMA. THE CONSUMER DID NOT SEEK MEDICAL ATTENTION AT THE TIME OF THE INCIDENT AND SAW A DERMATOLOGIST THREE DAYS LATER. HE RECEIVED WOUND CARE MGMT AND ANTIBIOTIC TREATMENT FOR A SUBSEQUENT INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ICY HOT HEAT THERAPY PATCH IMD CHATTEM, INC. 083 07A103

    Patients

    Seq Age Sex Outcome Treatment
    1 OMEPRAZOLE