BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LUMEX IMPERIAL THREE-IN-ONE DROP ARM COMMODE

    MDR report key: 2422959 · Received January 17, 2012

    Report

    Report Number
    2422959
    Event Type
    Injury
    Date Received
    January 17, 2012
    Date of Event
    December 28, 2011
    Report Date
    January 17, 2012
    Manufacturer
    GF HEALTH PRODUCTS, INC.
    Product Code
    INB
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    A LARGE PATIENT POST BILATERAL QUAD TENDON REPAIR SURGERY WAS TRANSFERRING TO THE COMMODE WHEN THE DROP-ARM ON THE COMMODE RELEASED CAUSING THE PATIENT TO USE HIS LEG TO CATCH HIMSELF. HE RE-RUPTURED HIS LEFT QUAD TENDON AND REQUIRED ADDITIONAL SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LUMEX IMPERIAL THREE-IN-ONE DROP ARM COMMODE DROP-ARM COMMODE INB GF HEALTH PRODUCTS, INC. 6438A *

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Hospitalization| R