BEUDAMED
    FDA Adverse Event Death Summary report: N

    SECURE-ALL ONE PIECE BODY HOLDER

    MDR report key: 98472 · Received June 13, 1997

    Report

    Report Number
    1625443-1997-00004
    Event Type
    Death
    Date Received
    June 13, 1997
    Date of Event
    May 9, 1997
    Report Date
    June 12, 1997
    Manufacturer
    TECNOL MEDICAL PRODUCTS, INC.
    Product Code
    FMQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE PATIENT WAS IN A VEST POSEY. AT 3:28 A.M. THE PATIENT WAS FOUND OUT OF BED, KNEELING ON THE FLOOR. THE PATIENT'S LEFT ARM WAS OUT OF THE POSEY WITH THE VEST OVER THE PATIENT'S HEAD. NO PULSE OR RESPIRATION WAS NOTED. THE PATIENT WAS LIFTED BACK INTO BED. CODE BLUE WAS INSTITUTED BUT WAS UNSUCCESSFUL. THE CASE WAS REPORTED TO THE CORONER'S OFFICE. THE FINAL AUTOPSY REPORT WILL BE ISSUED IN 4-6 WEEKS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SECURE-ALL ONE PIECE BODY HOLDER RESTRAINT, VEST FMQ TECNOL MEDICAL PRODUCTS, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR Death