BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOMATICS THYMATRON DGX

    MDR report key: 253606 · Received December 8, 1999

    Report

    Report Number
    253606
    Event Type
    Malfunction
    Date Received
    December 8, 1999
    Date of Event
    November 23, 1999
    Report Date
    November 23, 1999
    Manufacturer
    SOMATICS
    Product Code
    GXC
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING ECT TREATMENT E. PAD ON LEFT TEMPLE STARTED TO SMOKE. LESS THAN 1 CM REDDENED AREA NOTED ON LEFT TEMPLE. TRIPLE ANTIBIOTIC TO THE LEFT TEMPLE. 12-7-99 FOLLOW UP W/PT. NURSING HOME REPORTS THAT THE AREA (ABOUT 2 CM) IS STILL THERE. IT IS CLEAN AND DOING NICELY. THEY ARE PUTTING BACITRACIN ON IT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SOMATICS THYMATRON DGX ECT STIMULATOR GXC SOMATICS DGX 344161 K9(E PAD)

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Other