BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ICYHOT MEDICATED PATCHES

    MDR report key: 1029631 · Received April 13, 2008

    Report

    Report Number
    MW5006244
    Event Type
    Injury
    Date Received
    April 13, 2008
    Date of Event
    January 5, 2008
    Report Date
    April 13, 2008
    Manufacturer
    CHATTEM INC
    Product Code
    IMD
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    EXPERIENCED EXTREME DIFFICULTY IN REMOVING ICYHOT MEDICATED PATCH. FELT LIKE I WAS BEING SKINNED ALIVE. MY WIFE HAD THE SAME EXPERIENCE AS I DID WHEN SHE USED THE PRODUCT. I EMAILED CHATTEM INC ABOUT THE ADVERSE EVENT, BUT TO DATE HAVE NOT HAD ANY RESPONSE. DATES OF USE: 2007- 2008. DIAGNOSIS OR REASON FOR USE: BACK PAIN. EVENT ABATED AFTER USE STOPPED OR DOSE REDUCED? YES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ICYHOT MEDICATED PATCHES NONE IMD CHATTEM INC G047

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR