BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ECTONUSTIM

    MDR report key: 19060146 · Received April 5, 2024

    Report

    Report Number
    MW5153618
    Event Type
    Injury
    Date Received
    April 5, 2024
    Date of Event
    January 4, 2018
    Report Date
    April 3, 2024
    Manufacturer
    ECTRON LIMITED
    Product Code
    QGH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IA, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    I WAS INVOLUNTARILY COMMITTED AND AFTER 3 MONTHS OF BEING HOSPITALIZED WHEN I WAS GIVEN HALDOL ALTHOUGH IT WAS ON MY ALLERGY LIST AND NOT KNOWING WHAT MEDICATIONS TO PRESCRIBE THE LAST RESULT WAS ECTS(ELECTROCONVULSIVE THERAPIES) WHICH MYSELF OR MY FAMILY WAS NOT ABLE TO GIVE ANY CONSENT TO ESPECIALLY MY HUSBAND IT WAS ORDERED FROM THE PSYCHIATRIST TO THE JUDGE TO ORDER IT I EVEN HAD TO DO IT AFTER I GOT OUT OF THE HOSPITAL UNTIL THE COURT ORDER WAS OVER AFTERWARDS. I HAD PROBLEMS AT MY JOB, I COULDN'T FOCUS, I HAD BRAIN FOG. I WAS TIRED CONSTANTLY. I COULDN'T REMEMBER ANYTHING, MY ANXIETY WAS HIGHER I WAS MORE PARANOID AND I ENDED UP HAVING TO FILE FOR DISABILITY. I DID NOT HAVE ANY TESTING BEFORE GIVEN ECTS(I DID NOT HAVE ANY TESTING BEFORE GIVEN ECTS). REASON FOR USE: BIPOLAR. THE PROBLEMS DID NOT STOP AFTER USING THE PRODUCT. DIDN'T RESTART USING THE PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    607005 ECTONUSTIM ELECTROCONVULSIVE THERAPY DEVICE FOR CATATONIA, MAJOR DEPRESSIVE DISORDER, AND B QGH ECTRON LIMITED

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Female Disability| H ATENOLOL| QUETIAPINE| TRILEPTAL| ZOLOFT