BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOMATICS, LLC

    MDR report key: 10466656 · Received August 28, 2020

    Report

    Report Number
    1420295-2020-00011
    Event Type
    Injury
    Date Received
    August 28, 2020
    Report Date
    August 28, 2020
    Manufacturer
    SOMATICS, LLC
    Product Code
    GXC
    PMA / PMN Number
    945120
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    (B)(6) CLAIMED MULTIPLE INJURIES IN A LAWSUIT FILING. THESE INCLUDED NOT WARNING HER ABOUT BRAIN DAMAGE, OTHER COGNITIVE EFFECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    933464 SOMATICS, LLC ELECTROCONVULSIVE THERAPY INSTRUMENT GXC SOMATICS, LLC N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Other