BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMOTEX

    MDR report key: 1544146 · Received November 13, 2009

    Report

    Report Number
    1528424-2009-00006
    Event Type
    Injury
    Date Received
    November 13, 2009
    Date of Event
    November 5, 2009
    Report Date
    November 12, 2009
    Manufacturer
    THERMOTEX THERAPY SYSTEMS LTD.
    Product Code
    IRT
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    WI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    THE HUSBAND OF THE PERSON THAT HAD THE ADVERSE EVENT CONTACTED OUR CUSTOMER SERVICE REPRESENTATIVE ON (B) (6) 2009 AND STATED THAT HIS WIFE HAD FALLEN ASLEEP WITH THE HEATING PAD ON HER BODY FOR 45 MINUTES TO 1 HOUR AND RECEIVED RED BURNS TO HER ARM SHOULDER AND CHEST. HE STATED THAT THE UNIT WAS ACCIDENTALLY LEFT ON HIGH. THEY UNDERSTOOD FROM THE DIRECTIONS THAT THE UNIT SHOULD NOT BE USED ON HIGH FOR MORE THAN 15 MINUTES BUT THAT SHE FELL ASLEEP. THE BURNS DID NOT BLISTER, JUST BECAME VERY RED. AFTER 1 WEEK, THE BURNS ARE BARELY VISIBLE. THE CONSUMER LOVES USING THE HEATING PAD AND DOES NOT DESIRE TO RETURN IT TO THE MANUFACTURER. SHE FEELS THE PAD WORKS FINE, THAT IT WAS HER ERROR THAT CAUSED THE BURNS. SHE HAS BEEN USING THE HEATING PAD FOR ARTHRITIS PAIN ALMOST EVERY DAY FOR APPROXIMATELY 1 YEAR. SHE WILL CONTINUE TO USE THE PAD BUT ONLY ON THE LOW HEAT SETTING. NO MEDICAL ATTENTION WAS NEEDED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Other