BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ICY HOT HEAT THERAPY

    MDR report key: 1022041 · Received March 31, 2008

    Report

    Report Number
    MW5006054
    Event Type
    Injury
    Date Received
    March 31, 2008
    Date of Event
    March 21, 2008
    Report Date
    March 31, 2008
    Manufacturer
    CHATTEM INC.
    Product Code
    IMD
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    RECEIVED NUMEROUS BLISTERING BURNS AND SKIN TORE OFF WHEN PATCH WAS REMOVED FROM USE OF ICY HOT HEAT THERAPY SMALL AREA PATCHES. DOSE OR AMOUNT: 1 PATCH, FREQUENCY: 8 HOURS, ROUTE: TRANSDERMAL. DATE OF USE: 8 HOURS IN 2008. DIAGNOSIS OR REASON FOR USE: SHOULDER AND NECK PAIN/MUSCLE STRAIN. 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 AIR ACTIVATED HEAT PATCH IMD CHATTEM INC. A6Y3

    Patients

    Seq Age Sex Outcome Treatment
    1 Other