BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMOTEX

    MDR report key: 1671196 · Received April 27, 2010

    Report

    Report Number
    1528424-2010-00003
    Event Type
    Injury
    Date Received
    April 27, 2010
    Date of Event
    December 1, 2009
    Report Date
    April 26, 2010
    Manufacturer
    THERMOTEX THERAPY SYSTEMS LTD.
    Product Code
    IRT
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    MT, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    (B)(6) CONTACTED CUSTOMER SERVICE ON (B)(6) 2010 AND STATED THAT HER HUSBAND RECEIVED 2ND DEGREE BURNS FROM USING THE THERMOTEX HEATING PAD ON HIS KNEE. (B)(4) WAS CONTACTED ON (B)(6) 2010 AND STATED THE FOLLOWING: HE PURCHASED THE UNIT APPROXIMATELY 5 YEARS AGO AND HAS BEEN USING IT REGULARLY SINCE. IN (B)(6) 2009, HE FELL ASLEEP WITH THE PAD ON HIS KNEE AND AWOKE TO A BURNING SENSATION AND 3 BURN SPOTS ON HIS KNEE. HE FEELS HE WAS SLEEPING AT LEAST 15 MINUTES OR MORE. HE CONTACTED HIS DOCTOR VIA TELEPHONE AND DESCRIBED THE BURNS, THE DOCTOR DID NOT FEEL HE NEEDED TO BE SEEN AND INSTRUCTED HIM TO KEEP IT CLEAN AND TO COME IN IF IT GOT WORSE. HE FEELS IT TOOK APPROXIMATELY 4 MONTHS FOR THE BURN SPOTS TO BE TOTALLY HEALED. (B)(6) ALSO SUFFERS FROM NEUROPATHY AND DIABETES. HE DID NOT RETURN THE UNIT, HE CUT THE CORD OFF AND DISCARDED IT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Other