BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ICYHOT HEAT THERAPY PATCHES

    MDR report key: 1202363 · Received October 14, 2008

    Report

    Report Number
    MW5008666
    Event Type
    Injury
    Date Received
    October 14, 2008
    Report Date
    October 14, 2008
    Manufacturer
    CHATTEM, INC.
    Product Code
    IMD
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NJ, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I APPLIED AN "ICYHOT HEAT THERAPY" AIR ACTIVATED HEAT PATCH TO MY LOWER BACK AND BACKSIDE TO TRY TO RELIEVE SOME OF THE PAIN FROM A SERIOUS, DISABLING BACK PROBLEM THAT I SUFFER FROM. I DEVELOPED NUMEROUS BLISTERS ON MORE THAN 1/2 THE AREA THAT HAD BEEN COVERED BY THE PATCH. THE BLISTERS HAVE ALL BROKE AND THE SKIN IS BOTH RAW AND BLEEDING AND QUITE UNCOMFORTABLE. I AM USING A TRIPLE ANTIBIOTIC CREAM BUT THE HEALING PROCESS IS GOING SLOW AND SINCE THE AREA OF THE BACK IS NOT READABLY EXPOSED TO FRESH AIR IT IS GOING TO TAKE AWHILE. APPROXIMATELY 6 MONTHS AGO I USED ONE OF THESE PATCHES THAT I RECEIVED AS A SAMPLE AND THE SAME THING HAPPENED BUT I ASSUME THAT I HAD LEFT IT ON TOO LONG-ABOUT 8 HRS.- SO THIS TIME I ONLY LEFT IT ON FOR 6 HOURS AND IT FEELS LIKE ITS MUCH WORSE, IN FACT I HAVE AN APPOINTMENT WITH MY PHYSICIAN FOR TOMORROW SINCE I HAVE NO CAR TODAY. HOPEFULLY I CAN GET A CREAM THAT WILL HELP SPEED UP THE HEALING PROCESS. IF IT WASN'T FOR MY TEENAGE DAUGHTER TELLING ME TO "GOOGLE" IT, I WOULD NEVER HAD KNOWN ABOUT THE RECALL ON THIS PRODUCT AND HENCE THIS REPORT. DOSE OR AMOUNT: 1 LARGE BACK PATCH. FREQUENCY: LASTS 8 HOURS. ROUTE: OTHER. DATES OF USE: 4 HRS. DIAGNOSIS OR REASON FOR USE: SEVERE 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 PATCHES NONE IMD CHATTEM, INC. 3A7RD

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Other