BEUDAMED
    FDA Adverse Event Other Summary report: N

    ICY HOT AIR ACTIVATED NECK

    MDR report key: 1003372 · Received February 22, 2008

    Report

    Report Number
    MW5005656
    Event Type
    Other
    Date Received
    February 22, 2008
    Date of Event
    December 10, 2007
    Report Date
    February 22, 2008
    Manufacturer
    *
    Product Code
    IMD
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IL, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    EXPERIENCED IRRITATION AFTER 2 HOURS WITH ICY HOT AIR ACTIVATED NECK WRAP. AFTER REMOVAL OF WRAP AREA REMAINED RED AND TENDER TO THE TOUCH. DOSE OR AMOUNT: ONE, FREQUENCY: 2 HOURS, ROUTE: SUBDERMAL. DATES OF USE: 2007. DIAGNOSIS OR REASON FOR USE: ARTHRITIS. EVENT ABATED AFTER USE STOPPED OR DOSE REDUCED? YES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ICY HOT AIR ACTIVATED NECK NONE IMD * * *

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Other