BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMOTEX

    MDR report key: 1215451 · Received October 23, 2008

    Report

    Report Number
    1528424-2008-00011
    Event Type
    Injury
    Date Received
    October 23, 2008
    Date of Event
    August 10, 2007
    Report Date
    October 23, 2008
    Manufacturer
    THERMOTEX THERAPY SYSTEMS LTD.
    Product Code
    IRT
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    CORPORATE COUNCIL WAS CONTACTED BY AN ATTORNEY THAT STATED SHE RECEIVED BURNS ON HER BACK FROM THE THERMOTEX HEATING PAD. NO FURTHER INFORMATION REGARDING THE EVENT OR ANY MEDICAL ATTENTION THAT WAS NECESSARY WAS INCLUDED. IF/WHEN FURTHER INFORMATION IS RECEIVED, THIS REPORT WILL BE AMENDED.

    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 UNK Other