BEUDAMED
    FDA Adverse Event Other Summary report: N

    AC-POWERED ADJUSTABLE HOSPITAL BED, INCLUDING RAILS

    MDR report key: 2083111 · Received April 29, 2011

    Report

    Report Number
    1525712-2011-00180
    Event Type
    Other
    Date Received
    April 29, 2011
    Date of Event
    March 23, 2011
    Report Date
    April 29, 2011
    Manufacturer
    UNK
    Product Code
    FNL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE FACILITY ALLEGEDLY FOUND THE RESIDENT WITH HIS ARM STUCK BETWEEN THE BED RAILS. THE FACILITY STATES THEY BELIEVE THE RESIDENT SLIPPED WHEN HE WAS CLIMBING BACK INTO BED FROM USING THE BATHROOM. THE STAFF HAS BEEN ADVISED TO LEAVE THE BEDRAIL DOWN TO PREVENT THIS FROM ALLEGEDLY REOCCURRING. NO ALLEGATION OF SERIOUS INJURY. MDR FILED SOLELY ON ALLEGATION OF ARM ENTRAPMENT.

    Description of Event or Problem · 1

    THE FACILITY ALLEGES THEY FOUND A RESIDENT KNEELING ON THE FLOOR AT HIS BEDSIDE WITH HIS ARM STUCK BETWEEN THE BEDRAILS. NO SERIOUS INJURY IS ALLEGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AC-POWERED ADJUSTABLE HOSPITAL BED, INCLUDING RAILS 880.5100 FNL UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1