BEUDAMED
    FDA Adverse Event Death Summary report: N

    M-RAIL

    MDR report key: 759182 · Received June 1, 2006

    Report

    Report Number
    759182
    Event Type
    Death
    Date Received
    June 1, 2006
    Date of Event
    May 24, 2006
    Report Date
    May 31, 2006
    Manufacturer
    *
    Product Code
    FNJ
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IN 2006, ET WAS FOUND ON THE FLOOR WITH HER BODY LEANING AGAINST THE BED AND HER NECK CAUGHT ON THE INSIDE EDGE OF THE M-RAIL LOWER BAR THAT SLIDES UNDER THE MATTRESS. SHE HAD EXPIRED. THE M-RAIL WAS AJAR AND ANGLED AWAY FROM THE BED, IT WAS NOT TIGHT AGAINST THE MATTRESS. FAMILY MEMBER REPORTED THAT SHE ATTACHED THE M-RAIL ONTO THE HOSPITAL BED AT HER MOTHER'S REQUEST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 M-RAIL M-RAIL FNJ * SAMMONS PRESTON *

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Death