BEUDAMED
    FDA Adverse Event Death Summary report: N

    POSEY SAFETY VEST

    MDR report key: 296354 · Received September 14, 2000

    Report

    Report Number
    296354
    Event Type
    Death
    Date Received
    September 14, 2000
    Date of Event
    September 1, 2000
    Report Date
    September 13, 2000
    Manufacturer
    J.T. POSEY CO
    Product Code
    FMQ
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THIS ELDERLY DEPRESSED FEMALE COMMITTED SUICIDE BY TAKING A POSEY SAFETY VEST NOT IN USE AND PLACING IT AROUND HER NECK AND ATTACHING IT TO FAUCETS IN A SHOWER.

    Description of Event or Problem · 1

    ADD'L INFO REC'D FROM MFR 10/13/00: MFR HAS DETERMINED THIS IS NOT A MDR REPORTABLE EVENT TO THE FDA FOR THE FOLLOWING REASONS: 1. NO MALFUNCTION OF DEVICE, 2. THE TAKING OF DEVICE AND WRAPPING AROUND NECK AND ATTACHING TO FAUCET IS UNREASONABLE ABUSE OF DEVICE, AND OUTSIDE OF MFR INTENDED USE. 3. NO REASONABLE PERSON WOULD CONCLUDE THAT THIS SUBJECT DEVICE CAUSED OR CONTRIBUTED TO THE INCIDENT ANYMORE THAN A ROPE, STRING, BELT, SHEET, ETC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POSEY SAFETY VEST POSEY VEST FMQ J.T. POSEY CO POSEY SAFETY VEST WITH BREEZELINE FABRIC WITH TIE ENDS *

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Death