BEUDAMED
    FDA Adverse Event Other Summary report: N

    SIDE RAILS

    MDR report key: 282410 · Received June 15, 2000

    Report

    Report Number
    2182305-2000-00016
    Event Type
    Other
    Date Received
    June 15, 2000
    Date of Event
    May 24, 2000
    Report Date
    June 15, 2000
    Manufacturer
    SUNRISE MEDICAL CCG
    Product Code
    FNJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED A RESIDENT WAS FOUND IN THE ROOM BETWEEN THE HALF RAILS. RESIDENT'S ARMS WERE HOLDING RESIDENT ON THE BED, AND FEET AND BOTTOM HALF OF BODY WERE OFF THE BED. ALL FOUR 1/2 RAILS WERE UP AND RESIDENT TRIED TO GET OUT OF BED BETWEEN THEM. RESIDENT WAS UNRESPONSIVE AND CYANOTIC WHEN FOUND. ADMITTED TO HOSP FOR 24 HOURS, RETURNED TO NURSING HOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SIDE RAILS SAFETY SIDE RAILS [ 1/2 RAILS] FNJ SUNRISE MEDICAL CCG F1401 *

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR Hospitalization