BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LUMEX

    MDR report key: 2114186 · Received May 20, 2011

    Report

    Report Number
    2114186
    Event Type
    Malfunction
    Date Received
    May 20, 2011
    Date of Event
    April 21, 2011
    Report Date
    April 27, 2011
    Manufacturer
    GF HEALTH PRODUCTS INC
    Product Code
    ITJ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TN, US

    Narratives

    Description of Event or Problem · 1

    A PATIENT WAS WALKING IN HOME WITH THE WALKER AND THE LEG OF THE WALKER BROKE AT THE RIVET. THE PATIENT FELL TO FLOOR AND BURNED THE LEG ON THE CARPET, BUT OTHERWISE HAD NO FURTHER INJURIES. THE WALKER WAS REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LUMEX ROLLING WALKER ITJ GF HEALTH PRODUCTS INC 716270A-4 *

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR NO OTHER THERAPIES