BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ICY HOT HEAT THERAPY

    MDR report key: 1001417 · Received February 19, 2008

    Report

    Report Number
    MW5005591
    Event Type
    Injury
    Date Received
    February 19, 2008
    Date of Event
    November 20, 2007
    Report Date
    February 19, 2008
    Manufacturer
    CHATTEM
    Product Code
    IMD
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    I WAS SEVERELY BURNED ON MY CALF IN TWO PLACES. I USED THIS THERAPY TO APPLY HEAT TO A CALF MUSCLE TO ALLOW IT TO RELAX. I DID NOT HAVE IT ON MORE THAN TWO HOURS. THIS WAS AROUND THANKSGIVING TIME. I MISSED WORK DAYS BECAUSE OF THE SEVERE PAIN AND BURN. WE APPLIED NEOSPORIN TO HELP IT HEAL. IT DID NOT HEAL RAPIDLY. I FINALLY WENT TO DR IN 2007. THE DR PRESCRIBED A SALVE TO HELP IT HEAL. THE DR ALLOWED ANOTHER TWO DAYS OF SICK LEAVE. IT IS NOW 2008. THE SCARS FROM THE BURN ARE STILL THERE. I HAVE PICTURES I CAN SEND YOU. I DO NOT GET PAID FOR SICK LEAVE. I FEEL THAT BESIDES THE PAIN AND SUFFERING I EXPERIENCED AND THE NON-PAY DAYS I SHOULD BE COMPENSATED MORE THAN THE COST OF THE PRODUCT. I REPORTED THIS TO CHATTEM THIS DATE ALSO. I UNDERSTAND THERE IS A RECALL OF THIS PRODUCT. DOSE OR AMOUNT: APPLIED PATCH TO CALF. FREQUENCY: 2 HOURS. ROUTE: UNK. DATES OF USE: ONE DAY IN 2007. DIAGNOSIS OR REASON FOR USE: CALF MUSCLE CRAMP. 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 NONE IMD CHATTEM 0 41167 08330

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Other| R