BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ICY HOT

    MDR report key: 1007127 · Received March 4, 2008

    Report

    Report Number
    MW5005775
    Event Type
    Injury
    Date Received
    March 4, 2008
    Date of Event
    February 18, 2008
    Report Date
    March 4, 2008
    Manufacturer
    CHATTEM, INC.
    Product Code
    IMD
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    I PURCHASED ICY HOT HEAT THERAPY AIR ACTIVATED HEAT PAD. WHEN I APPLIED IT TO MY SHOULDER, IT FELT REALLY HOT. AFTER SEVERAL MINS, IT GOT SO HOT I HAD TO REMOVE IT. AFTER REMOVING IT, I NOTICED THAT THE AREA WHERE THE PAD WAS APPLIED WAS VERY RED AND IRRITATED. AFTER A COUPLE DAYS THE REDNESS WENT AWAY. DATES OF USE: 2008 (15 MINS). DIAGNOSIS OR REASON FOR USE: I HAD SHOULDER PAIN FROM WORK.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR