BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOMATICS, LLC

    MDR report key: 11641186 · Received April 9, 2021

    Report

    Report Number
    1420295-2021-00002
    Event Type
    Injury
    Date Received
    April 9, 2021
    Date of Event
    March 31, 2021
    Report Date
    April 9, 2021
    Manufacturer
    SOMATICS, LLC
    Product Code
    GXC
    PMA / PMN Number
    945120
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN ANONYMOUS CALLER STATED ECT RUINED HIS/HER LIFE AND WAS GOING TO SUE THE COMPANY. WHEN ASKED TO PROVIDE CONTACT INFORMATION SO THE COMPANY COULD START AN INVESTIGATION, THE CALLER HUNG UP. THE PERSON HAS SLURRED SPEECH AS IF DRUNK. BECAUSE OF THE LACK OF IDENTIFYING INFORMATION AND SPECIFICS, SOMATICS IS UNABLE TO FOLLOW UP WITH ANY INVOLVED PARTIES TO LEARN MORE ABOUT WHAT MAY HAVE HAPPENED AND TO CONFIRM WHETHER THE COMPLAINANT WAS EVEN TREATED WITH ITS THYMATRON DEVICE. MOREOVER, THE MEDICAL LITERATURE PROVIDES NO EVIDENCE OF THE CONNECTION DRAWN BY THE COMPLAINANT BETWEEN ECT TREATMENT AND THE SYMPTOMS REPORTED. ALTHOUGH THE COMPANY HAS DETERMINED THAT THE SUBJECT EVENT IN THIS MDR IS LIKELY NOT REPORTABLE, BECAUSE SOMATICS IS UNABLE FOLLOW-UP WITH THE COMPLAINANT OR OTHERWISE AFFIRMATIVELY DETERMINE WHETHER THE DEVICE CAUSED OR CONTRIBUTED TO THE EVENT, AND/OR WHETHER THE ECT DEVICE IN QUESTION WAS EVEN THE ONE MANUFACTURED BY SOMATICS, THE COMPANY IS SUBMITTING THIS REPORT TO FDA IN AN ABUNDANCE OF CAUTION AND TO ENSURE FULL COMPLIANCE WITH 21 CFR PART 803.

    Description of Event or Problem · 1

    ANONYMOUS CALLER STATED ECT HAD RUINED HIS/HER LIFE AND WOULD SUE THE COMPANY. THE PERSON HAD SLURRED SPEECH AS IF DRUNK. WHEN ASKED TO SEND COMPLETE CONTACT INFORMATION THE PERSON HUNG UP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    539021 SOMATICS, LLC THYMATRON GXC SOMATICS, LLC N / A

    Patients

    Seq Age Sex Outcome Treatment
    1 Other