BEUDAMED
    FDA Adverse Event Death Summary report: N

    SA 1-PC. BODY HOLDER

    MDR report key: 135014 · Received November 24, 1997

    Report

    Report Number
    135014
    Event Type
    Death
    Date Received
    November 24, 1997
    Date of Event
    June 30, 1997
    Report Date
    November 10, 1997
    Manufacturer
    TECNOL MEDICAL PRODUCTS, INC.
    Product Code
    FMQ
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    OH, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT ADMITTED ON 6/24/97 FOR ORGANIC DELUSIONAL DISORDER. PHYSICIAN ORDERED RESTRAINT VEST FOR SAFETY AND REORDERED EVERY 24 HOURS THROUGH 6/29/97. ON 6/30/97 AT 7:02 AM PT FOUND FACE DOWN BETWEEN SIDERAILS, WITH ARMS AT APPROX. 120 ANGLE OVERHEAD. VEST RESTRAINT INTACT - REMOVED AND CPR INITIATED. CPR UNSUCCESSFUL. POST CPO REVIEW OF EVENT REVEALED THAT VEST RESTRAINT HAD BEEN APPLIED APPROPRIATELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SA 1-PC. BODY HOLDER PROTECTIVE RESTRAINT FMQ TECNOL MEDICAL PRODUCTS, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Death