BEUDAMED
    FDA Adverse Event Other Summary report: N

    ICY HOT HEAT THERAPY PATCH

    MDR report key: 1002923 · Received February 8, 2008

    Report

    Report Number
    1022556-2008-00031
    Event Type
    Other
    Date Received
    February 8, 2008
    Date of Event
    January 10, 2008
    Report Date
    January 15, 2008
    Manufacturer
    CHATTEM, INC.
    Product Code
    IMD
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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 MFR TO ENHANCE PRODUCT SAFETY AND PHARMACOVIGILANCE.

    Description of Event or Problem · 1

    THE CONSUMER USED THE PRODUCT ON HER THIRTEEN YEAR OLD DAUGHTER'S CALF FOR EIGHT HOURS. WHEN SHE REMOVED THE PATCH, THEY REALIZED THE SKIN WAS BURNED WITH MULTIPLE BLISTERS. THEY DID NOT SEEK MEDICAL ATTENTION AT THE TIME OF THE INCIDENT. THREE DAYS AFTER THE INCIDENT, THE BLISTERS BECAME INFECTED AND HER PRIMARY CARE PHYSICIAN PRESCRIBED ANTIBIOTICS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ICY HOT HEAT THERAPY PATCH IMD CHATTEM, INC. 083 2A7Q1

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR