BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ICY HOT HEAT THERAPY

    MDR report key: 1000337 · Received February 13, 2008

    Report

    Report Number
    MW5005554
    Event Type
    Injury
    Date Received
    February 13, 2008
    Date of Event
    February 8, 2008
    Report Date
    February 13, 2008
    Manufacturer
    CHATTEM, INC.
    Product Code
    IMD
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    USED ICY HOT HEAT THERAPY- AIR ACTIVATED PATCH- FOR MUSCLE STRAIN. I JUST STARTED PHYSICAL THERAPY AND WILL RECEIVE TREATMENT 3X PER WEEK. LAST FRIDAY, I USED A PATCH AND IT BURNED/BLISTERED THE SKIN ON MY SHOULDER AND BASE OF NECK. I SHOWED THIS TO THE PHYSICAL THERAPIST SATURDAY MORNING AT MY APPOINTMENT. HE HAD TO WORK AROUND THIS INJURY, AND EXAMINED IT THOROUGHLY AND TOLD ME ONE MORE SPOT WAS GOING TO BLISTER. I AM NOW NOT ABLE TO RECEIVE TREATMENT -DURING PHYSICAL THERAPY- ON THE PLACES WHERE I HAVE THE BLISTERS/BURNS. ONE BURN/BLISTER HAS CLOSED AND THE OTHER IS STILL AN OPEN WOUND. DATES OF USE: 2008. DIAGNOSIS OR REASON FOR USE: MUSCLE STRAIN....CURRENTLY IN PHYSICAL THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ICY HOT HEAT THERAPY AIR ACTIVATED HEAT PATCH IMD CHATTEM, INC. 2A7R4

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Required Intervention