BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EPAD THYMAPAD STIMULUS ELECTRODE

    MDR report key: 20782367 · Received November 26, 2024

    Report

    Report Number
    20782367
    Event Type
    Malfunction
    Date Received
    November 26, 2024
    Date of Event
    October 7, 2024
    Report Date
    October 10, 2024
    Manufacturer
    SOMATICS, LLC
    Product Code
    QGH
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 0

    ECT PAD SPARKED DURING PROCEDURE, RESULTING IN BURN TO PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2441790 EPAD THYMAPAD STIMULUS ELECTRODE ELECTRODE, CUTANEOUS QGH SOMATICS, LLC 24F004

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Male