BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LUMEX

    MDR report key: 76018 · Received January 17, 1997

    Report

    Report Number
    76018
    Event Type
    Injury
    Date Received
    January 17, 1997
    Date of Event
    July 27, 1996
    Report Date
    August 8, 1996
    Manufacturer
    LUMEX, DIV. OF LUMES, INC.
    Product Code
    FRJ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE PT USES A RECLINING GERI CHAIR. BECAUSE SHE IS UNABLE TO SIT-UP ON HER OWN THE STAFF USES PILLOWS AS PADDING FOR SUPPORT. AS A RESULT OF THE PRESSURE FROM THE PADDING THE SIDE PANELS WERE PUSHED OUT PLACING PRESSURE ON THE TIP HOOKS/PRONGS THAT HOLD THE PANELS IN PLACE. AS A RESULT OF THE PRESSURE THE HOOKS/PRONGS HOLDING THE PANEL BROKE OFF ON THE RIGHT SIDE AND ARE CRACKED ON THE LEFT SIDE. THE INJURY OCCURRED WHEN THE PT WAS IN A SITTING POSITION AND THE CHAIR WAS BEING MOVED INTO A RECLINING POSITION. THE PT'S RIGHT HAND CAUGHT ON THE BROKEN HOOK/PRONG AS THE CHAIR WAS BEING RECLINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LUMEX RECLINING GERI CHAIR FRJ LUMEX, DIV. OF LUMES, INC. 574L857 *

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Required Intervention
    2