BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THERMOGARD

    MDR report key: 469777 · Received July 1, 2003

    Report

    Report Number
    MW1028865
    Event Type
    Malfunction
    Date Received
    July 1, 2003
    Date of Event
    February 24, 2003
    Report Date
    February 24, 2003
    Manufacturer
    COMMED CORP
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    LA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PT FOR LEEP. ELECTRICAL RETURN PAD PLACED ON LEG. PT RECEIVED A BURN UNDER THE RETURN PAD WHERE THE WIRES CONNECT TO THE PAD. NO BREAK IN THE INSULATION OF THE PLASTIC WAS NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 THERMOGARD DISPERSIVE ELECTRODE GEI COMMED CORP REF 51-7810 0205201

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Other