BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECTRUM BY MECTA

    MDR report key: 10053483 · Received May 13, 2020

    Report

    Report Number
    3020533-2020-00002
    Event Type
    Injury
    Date Received
    May 13, 2020
    Date of Event
    June 24, 2015
    Report Date
    May 13, 2020
    Manufacturer
    MECTA CORPORATION
    Product Code
    GXC
    PMA / PMN Number
    K965070
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    INCREASED AMNESIC DISORDER FOLLOWING ECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    514749 SPECTRUM BY MECTA ECT DEVICE GXC MECTA CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 Other