BEUDAMED
    FDA Adverse Event Other Summary report: N

    LUMEX

    MDR report key: 189798 · Received September 30, 1998

    Report

    Report Number
    MW1014660
    Event Type
    Other
    Date Received
    September 30, 1998
    Date of Event
    July 9, 1998
    Report Date
    September 24, 1998
    Manufacturer
    LUMEX
    Product Code
    IOR
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MN, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    RESIDENT WAS BEING TRANSFERRED TO WHEELCHAIR. CALF OF RIGHT LEG REC'D LACERATION WHILE BEING TRANSFERRED. THE PART OF THE WHEELCHAIR THAT THE FOOTRESTS ATTACH TO COME IN CONTACT WITH RESIDENT'S SKIN. SUGGEST THAT THIS METAL PIECE BE CHANGED IN DESIGN TO PREVENT SKIN TEARS OR BRUISING. LACERATION OBTAINED WAS 4 CM TRIANGLE 1 CM DEEP. THE LEG RESTS WERE OFF THE CHAIR AT THE TIME OF THE INCIDENT. VENDER NOTIFIED BY DIRECTOR OF HEALTH CARE VIA PHONE AT THE TIME OF INCIDENT. SIMILAR INCIDENT WITH LESS SEVERE INJURY PRECEDED THIS ONE. WHEELCHAIR MODIFICATION BY SUPPLIER 8/98.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LUMEX WHEELCHAIR 5900 IOR LUMEX OG 427 *

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Other