BEUDAMED
    FDA Adverse Event Other Summary report: N

    GERI-CHAIR

    MDR report key: 34637 · Received July 25, 1996

    Report

    Report Number
    MW1009569
    Event Type
    Other
    Date Received
    July 25, 1996
    Date of Event
    July 9, 1996
    Report Date
    July 19, 1996
    Manufacturer
    LUMEX CORP.
    Product Code
    FRJ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    RESIDENT WAS BEING WHEELED TO DINING ROOM IN CHAIR. THE CHAIR WAS IN A SEMI-RECLINING POSITION. IT DISENGAGED AND PLACED THE RESIDENT IN AN UPRIGHT POSITION. HER FEET WENT TO THE FLOOR AND CAUGHT IN THE FORWARD MOVEMENT, RESULTING IN A NON-DISPLACED RIGHT DISTAL FRACTURE OF HER TIBIA AND FIBULA. TAKEN TO ER FOR X-RAY, AIR-CAST APPLIED, RETURNED TO FACILITY SAME DAY. RESIDENT IS NON-AMBULATORY. NO CHANGE IN ADL STATUS RESULTED FROM THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GERI-CHAIR GERIATRIC RECLINER FRJ LUMEX CORP. 1100

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Other