BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ICY HOT HEAT THERAPY

    MDR report key: 1037561 · Received April 28, 2008

    Report

    Report Number
    MW5006529
    Event Type
    Injury
    Date Received
    April 28, 2008
    Date of Event
    April 12, 2008
    Report Date
    April 28, 2008
    Manufacturer
    CHATTEM INC.
    Product Code
    IMD
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OH, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    BURN ON UPPER BACK LEFT SHOULDER FROM USING ICY HOT HEAT THERAPY PRODUCT THAT IS MANUFACTURED BY CHATTEM INC. DATES OF USE: 2008. DIAGNOSIS OR REASON FOR USE: SHOULDER PAIN. EVENT ABATED AFTER USE STOPPED OR DOSE REDUCED: YES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ICY HOT HEAT THERAPY NONE IMD CHATTEM INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other