BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMOTEX THERAPY SYSTEMS LTD

    MDR report key: 1900975 · Received November 12, 2010

    Report

    Report Number
    MW5018200
    Event Type
    Injury
    Date Received
    November 12, 2010
    Date of Event
    April 28, 2010
    Report Date
    November 5, 2010
    Manufacturer
    THERMOTEX THERAPY SYSTEMS LTD
    Product Code
    IRT
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OK, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    AFTER A LONG DAY, I WAS TIRED AND MY BACK ACHED (I HAVE HAD SEVERAL BACK SURGERIES). I LAID DOWN TO USE THE HEATING PAD, WHICH I HAD DONE BEFORE AND FELL ASLEEP FOR A WHILE. WHEN I WOKE UP, I HAD SEVERE PAIN IN MY BUTTOCKS AND REALIZED I HAD BEEN SEVERELY BURNED. I WAS DIAGNOSED WITH 3RD DEGREE BURNS AND ENDED UP HAVING SURGERY, REQUIRING HOME HEALTH NURSING CARE AND THE USE OF A WOUND VAC FOR SEVERAL WEEKS. IT WAS IMPORTANT WHEN I MADE THE PURCHASE THAT THEY STATED ON THEIR MARKETING LITERATURE IN SEVERAL PLACES, THAT THEIR PRODUCTS "WILL NOT BURN OR DEHYDRATE THE SKIN."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 THERMOTEX THERAPY SYSTEMS LTD HEATING PAD IRT THERMOTEX THERAPY SYSTEMS LTD TT550 PLATINUM

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Disability