BEUDAMED
    FDA Adverse Event Other Summary report: N

    ICY HOT HEAT THERAPY, AIR ACTIVATED HEAT PATCH

    MDR report key: 1003374 · Received February 24, 2008

    Report

    Report Number
    MW5005657
    Event Type
    Other
    Date Received
    February 24, 2008
    Date of Event
    December 15, 2007
    Report Date
    February 24, 2008
    Manufacturer
    CHATTEM
    Product Code
    IMD
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I USED THE ICY HOT THERAPY AIR ACTIVATED HEAT PATCH AND NOTICED THAT IT WAS VERY HOT AND WAS NOT GETTING COOLER SO I REMOVED THEM AFTER JUST THE MINUTES ON SKIN. IT LEFT BOILS ON MY SKIN. MY DR SAID THEY WERE SECOND DEGREE BURNS. THANK GOD I DIDN'T LEAVE THEM ON ANY LONGER. NO TELLING WHAT IT COULD HAVE DONE TO ME. I'M A HEART PATIENT AND I'M ON BLOOD THINNERS. I WAS SO WORRIED THAT THE BURNS WOULD OPEN UP AND CAUSE A INFECTION OR START BLEEDING. HAD TO WEAR LOOSE CLOTHES FOR ABOUT A MONTH UNTIL THE WOUNDS HEALED UP. I HAVE SOME SCARS FROM THE EVENT. DATES OF USE: 2007 FOR ONLY TEN MINUTES. DIAGNOSIS OR REASON FOR USE: HIP AND BACK PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ICY HOT HEAT THERAPY, AIR ACTIVATED HEAT PATCH NONE IMD CHATTEM * 3A7RG

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Other