BEUDAMED
    FDA Adverse Event Death Summary report: N

    CHEST AND WAIST RESTRAINT

    MDR report key: 94859 · Received May 30, 1997

    Report

    Report Number
    1417592-1997-00021
    Event Type
    Death
    Date Received
    May 30, 1997
    Date of Event
    February 25, 1997
    Report Date
    May 30, 1997
    Manufacturer
    MEDLINE INDUSTRIES, INC.
    Product Code
    FMQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    RESIDENT WITH CHEST AND WAIST JACKET RESTRAINT WAS FOUND DEAD AT 3:10AM. THE AUTOPSY FOUND THAT RESIDENT DIED OF HANGING CAUSED BY A RESTRAINT HARNESS. THE RESIDENT HAD BEEN LEFT UNATTENDED AND HAD LAST BEEN CHECKED TWO HOURS PREVIOUSLY (1AM). MEDICAL EXAMINER RULED DEATH ACCIDENTAL WITH SENILE DEMENTIA A CONTRIBUTING FACTOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CHEST AND WAIST RESTRAINT CHEST AND WASIT RESTRAINT FMQ MEDLINE INDUSTRIES, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Death