BEUDAMED
    FDA Adverse Event Other Summary report: N

    ICY HOT HEAT THERAPY PATCH

    MDR report key: 1002886 · Received February 11, 2008

    Report

    Report Number
    1022556-2008-00050
    Event Type
    Other
    Date Received
    February 11, 2008
    Report Date
    April 11, 2007
    Manufacturer
    CHATTEM, INC.
    Product Code
    IMD
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CONSUMER KNOWINGLY USED THE PATCH OFF-LABEL BY WEARING FOR LONGER THAN EIGHT HOURS. THE CONSUMER MAY HAVE ALSO USED THE PRODUCT OFF-LABEL BY PUTTING PRESSURE ON THE PRODUCT WHILE WEARING. SINCE THIS IS A DISPOSABLE SINGLE-USE DEVICE, THE PATCH IS UNAVAILABLE FOR EVALUATION AND ANALYSIS. THE UNUSED PORTION OF THE PRODUCT HAS BEEN RETURNED TO THE MANUFACTURER. 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 PATIENT 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 FOR LONGER THAN EIGHT HOURS ON HIS LOWER BACK. THE PATCH WAS PAINFUL TO REMOVE AND TORE THE SKIN IN THREE SEPARATE LOCATIONS WHICH BLED. THE CONSUMER DID NOT SEEK MEDICAL ATTENTION AT THE TIME OF THE INCIDENT AND TREATED THE AREA WITH NUSKIN. THE INJURY TOOK APPROXIMATELY TWO WEEKS TO HEAL AND LEFT THREE SCARS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ICY HOT HEAT THERAPY PATCH IMD CHATTEM, INC. 083 3A6Z1

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR