BEUDAMED
    FDA Adverse Event Other Summary report: N

    AC-POWERED ADJUSTABLE HOSPITAL BED, INCLUDING RAILS

    MDR report key: 2083101 · Received April 29, 2011

    Report

    Report Number
    1525712-2011-00179
    Event Type
    Other
    Date Received
    April 29, 2011
    Date of Event
    March 20, 2011
    Manufacturer
    INVACARE CONTINUING CARE GROUP
    Product Code
    FNL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE FACILITY ALLEGEDLY FOUND THE RESIDENT WITH HIS KNEE STUCK BETWEEN TWO OF THE ASSIST RAILS. THE FACILITY STATES THIS IS AN ISOLATED OCCURRENCE WHERE THE RESIDENTS LEG AND KNEE WERE SMALL ENOUGH TO FIT THROUGH THE BARS ON THE BED RAILS. THE PRODUCT IS STILL IN USE BY THIS PT AT THIS FACILITY. THERE IS NO ALLEGED INJURY. FILING MDR BASED ON ALLEGATION OF KNEE ENTRAPMENT. NO FURTHER ACTION IS INDICATED.

    Description of Event or Problem · 1

    THE RESIDENT WAS FOUND WITH HIS KNEE ALLEGEDLY STUCK IN BETWEEN TWO OF THE ASSIST RAIL BARS. NO 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 INVACARE CONTINUING CARE GROUP ECHO BED

    Patients

    Seq Age Sex Outcome Treatment
    1