BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LUMEX

    MDR report key: 6033727 · Received October 17, 2016

    Report

    Report Number
    2428983-2016-00004
    Event Type
    Injury
    Date Received
    October 17, 2016
    Date of Event
    October 26, 2014
    Report Date
    October 17, 2016
    Manufacturer
    GF HEALTH PRODUCTS, INC.
    Product Code
    FNL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    THE HEAD END, FOOT END, AND CASTERS ARE MANUFACTURED AND DESIGNED BY APEX HEALTH CARE MANUFACTURING, INC. AND SOLD AS PART OF A BED PACKAGE WITH THE LUMEX PATRIOT HOMECARE BED. THE CASTERS ARE UNIVERSAL CASTERS DESIGNED BY APEX HEALTH CARE. THE BED FRAME SLEEP SURFACE WAS MANUFACTURED BY GF HEALTH PRODUCTS, INC. IT CANNOT BE DETERMINED BY THE PHOTOGRAPHS IF THE CASTERS SUBJECT TO THIS REPORT WERE SOLD WITH THE ORIGINAL BED PACKAGE. THE EROSION/RUST ON THE CASTERS SUPPORT THEY WERE NOT MAINTAINED.

    Description of Event or Problem · 1

    CIVIL ACTION STATES ON OR ABOUT (B)(6) 2014 THE END-USER WAS NEGOTIATING AROUND HIS BED WHEN HIS FOOT AND TOES HIT A PROTRUDING METAL LOCK ON THE WHEEL CASTER OF THE PATRIOT MODEL BED. THE END-USER HAD A HISTORY OF DIABETES AND THE INJURY TO HIS TOES AND FOOT LED TO MULTIPLE AMPUTATIONS OF HIS TOES, THEN PARTIAL FOOT AND THEN COMPLETE FOOT AMPUTATION. THE COMPLAINT ALLEGES IMPROPER CASTER DESIGN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    685299 LUMEX PATRIOT SEMI-ELECTRIC HOMECARE BED FNL GF HEALTH PRODUCTS, INC. US0208

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability