BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ICY HOT HEAT THERAPY

    MDR report key: 999882 · Received February 12, 2008

    Report

    Report Number
    MW5005503
    Event Type
    Injury
    Date Received
    February 12, 2008
    Date of Event
    January 8, 2008
    Report Date
    February 12, 2008
    Manufacturer
    CHATTEM, INC
    Product Code
    IMD
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MI, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I USED ICY HOT HEAT THERAPY ARM NECK & LEG CHATTEM INC AS DIRECTED AND REMOVED IT BEFORE THE RECOMMENDED TIME LIMIT. LOT CODE 2A75A. AS I REMOVED IT, MY SKIN CAME OFF WITH THE PATCH. THE SKIN ON MY THIGH WAS RED AND BLOODY AND BURNING. AS TIME WENT BY, I NOW HAVE PERMANENT SCARRING. I USED ICY HOT FOR 7 HOURS IN 2008. DIAGNOSIS OR REASON FOR USE: HIP PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ICY HOT HEAT THERAPY ARM NECK & LEG IMD CHATTEM, INC 2A75A

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Other