BEUDAMED
    FDA Adverse Event Death Summary report: N

    SECURE-ALL ONE PIECE BODY HOLDER

    MDR report key: 106953 · Received July 18, 1997

    Report

    Report Number
    106953
    Event Type
    Death
    Date Received
    July 18, 1997
    Date of Event
    May 9, 1997
    Report Date
    May 15, 1997
    Manufacturer
    TECNOL, INC.
    Product Code
    FMQ
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    IL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE PT WAS IN A VEST POSEY. AT 3:28 A.M. THE PT WAS FOUND OUT OF BED, KNEELING ON THE FLOOR. THE PT'S LEFT ARM WAS OUT OF THE POSEY WITH THE VEST OVER THE PT'S HEAD. NO PULSE OR RESPIRATION WAS NOTED. THE PT 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 VEST POSEY FMQ TECNOL, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR Death