BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ICYHOT HEAT THERAPY

    MDR report key: 1050104 · Received May 25, 2008

    Report

    Report Number
    MW5006981
    Event Type
    Injury
    Date Received
    May 25, 2008
    Date of Event
    May 19, 2008
    Report Date
    May 25, 2008
    Product Code
    IMD
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    AP, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    AFTER USING ICY HOT HEAT THERAPY BACK PATCH, I RECEIVED A SEVERE RASH AND BURNS AS A RESULT OF USING THE PATCH. DOSE OR AMOUNT: 1 LARGE PATCH FOR BACK; FREQUENCY: 1 USE. DATES OF USE: HOURS: 2008. 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 NONE IMD 3A6ZB

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Disability