BEUDAMED
    FDA Adverse Event Other Summary report: N

    ICY HOT HEAT THERAPY PATCH

    MDR report key: 1081102 · Received July 2, 2008

    Report

    Report Number
    1022556-2008-00581
    Event Type
    Other
    Date Received
    July 2, 2008
    Date of Event
    April 15, 2008
    Report Date
    June 17, 2008
    Manufacturer
    CHATTEM, INC.
    Product Code
    IMD
    Removal / Correction Number
    Z-1197-2008
    Adverse Event
    Yes
    Report Source
    Manufacturer report

    Narratives

    Additional Manufacturer Narrative · 1

    SINCE THIS IS A DISPOSABLE SINGE-USE DEVICE, THE PATCH IS UNAVAILABLE FOR EVAL AN 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 MANUFACTURER TO ENHANCE PRODUCT SAFETY AND PHARMACOVIGILANCE.

    Description of Event or Problem · 1

    A NURSE REPORTED THAT THE PT APPLIED THE PROD TO HER LEFT POSTERIOR THIGH/GLUTEAL AREA FOR SIX HRS. WHEN THE PATCH WAS REMOVED DUE TO A BURNING/STINGING SENSATION, THE AREA WAS DESCRIBED AS DARK RED WITH SMALL BLISTERS, TENDER TO TOUCH WITH OOZING OF CLEAR FLUID AND A DARK RAISED PURPLE/RED AREA IN THE CENTER. THE NURSE DESCRIBED THE WOUND AS RESEMBLING THAT OF A VOLATILE CHEMICAL BURN.

    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