BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ICYHOT HEAT THERAPY

    MDR report key: 1037906 · Received May 3, 2008

    Report

    Report Number
    MW5006639
    Event Type
    Malfunction
    Date Received
    May 3, 2008
    Date of Event
    January 15, 2008
    Report Date
    May 3, 2008
    Manufacturer
    CHATTEM, INC.
    Product Code
    IMD
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    SECOND DEGREE BURN ON SKIN WHEN USING ICYHOT HEAT THERAPY MADE BY CHATTEM, INC. DOSE OR AMOUNT: SINGLE PATCH, FREQUENCY: ONCE, ROUTE: CUTANEOUS. DATES OF USE: ONCE. DIAGNOSIS OR REASON FOR USE: BACK PAIN. EVENT ABATED AFTER USE STOPPED OR DOSE REDUCED: NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ICYHOT HEAT THERAPY BACK PATCH IMD CHATTEM, INC. 3A7RA

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR