BEUDAMED
    FDA Adverse Event Death Summary report: N

    *

    MDR report key: 2973671 · Received February 12, 2013

    Report

    Report Number
    2973671
    Event Type
    Death
    Date Received
    February 12, 2013
    Date of Event
    February 10, 2013
    Report Date
    February 12, 2013
    Manufacturer
    E.M. ADAMS CO, INC
    Product Code
    FMQ
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PATIENT WAS PLACED IN RESTRAINT ROLL BELT AS PATIENT HAD ATTEMPTED TO GET OUT OF BED MULTIPLE TIMES, 4 SIDE RAILS UP. RESTRAINT PLACED ON IMMOVABLE PART OF BED. HOWEVER, PATIENT FOUND AT LATER THAT DAY ON THE FLOOR, STILL IN ROLL BELT, FACE WAS BLUE AND PATIENT HAD EXPIRED. PATIENT EXPIRED WITH RESTRAINT ROLL BELT ON. IT IS UNCLEAR WHETHER RESTRAINT CONTRIBUTED TO DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    62142 * RESTRAINT, PROTECTIVE FMQ E.M. ADAMS CO, INC EP90484PB *

    Patients

    Seq Age Sex Outcome Treatment
    1 97 YR Death NO OTHER THERAPIES