BEUDAMED
    FDA Adverse Event Death Summary report: N

    TECHNOL BODY HOLDER

    MDR report key: 13900 · Received March 29, 1994

    Report

    Report Number
    13900
    Event Type
    Death
    Date Received
    March 29, 1994
    Date of Event
    March 13, 1994
    Report Date
    March 25, 1994
    Manufacturer
    TECHNOL, INC.
    Product Code
    FMQ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    A 34-YR-OLD PT WAS SITTING IN A CHAIR, RESTRAINED WITH A JACKET. THE PT WAS RESTLESS AND CALLING OUT AND HAD BEEN PLACED IN HIS ROOM. WHEN THE NURSE CAME IN TO GIVE MEDICATIONS, THE PT WAS FOUND SLUMPED FORWARD IN HIS CHAIR, WITH THE JACKET TIGHT AROUND HIS NECK. HE DID NOT APPEAR TO BE BREATHING OR RESPONSIVE. HELP WAS CALLED FOR AND THE HOUSE STAFF PHYSICIAN PRONOUNCED HIM DEAD. (SAME PT REFERRED TO IN 050457-1994-9003.)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TECHNOL BODY HOLDER PATIENT RESTRAINT BODY HOLDER FMQ TECHNOL, INC. UNKNOWN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Death