BEUDAMED
    FDA Adverse Event Other Summary report: N

    ICY HOT HEAT THERAPY PATCH

    MDR report key: 1031084 · Received April 15, 2008

    Report

    Report Number
    1022556-2008-00489
    Event Type
    Other
    Date Received
    April 15, 2008
    Date of Event
    February 26, 2008
    Report Date
    March 25, 2008
    Manufacturer
    CHATTEM, INC.
    Product Code
    IMD
    Removal / Correction Number
    Z-1196-2008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CONSUMER USED THE PRODUCT OFF-LABEL BY WEARING THE PATCH WHILE SLEEPING. SINCE THIS IS A DISPOSABLE SINGLE-USE DEVICE, THE PATCH IS UNAVAILABLE FOR EVAL AND ANALYSIS. THE LOT NUMBER WAS NOT PROVIDED FROM THE REPORTER TO CONDUCT TREND 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 COMSUMER REPORTED USING THE PRODUCT FOR SIX HOURS ON HER STOMACH WHILE SLEEPING. WHEN THE PATCH WAS REMOVED, THE CONSUMER DESCRIBED A BURN WITH BLISTERS THAT RUPTURED AND CAUSED SKIN LOSS IN THE AREA WORN. NO FURTHER DETAIL WAS PROVIDED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN