BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LUMEX

    MDR report key: 5986609 · Received September 29, 2016

    Report

    Report Number
    2428983-2016-00001
    Event Type
    Injury
    Date Received
    September 29, 2016
    Date of Event
    April 14, 2016
    Report Date
    September 28, 2016
    Manufacturer
    BLISS HEALTH PRODUCTS CO. LTD
    Product Code
    IPS
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    FL, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2016: THE END-USER'S ATTORNEY STATED HIS DISABLED CLIENT WAS USING THE QUAD CANE WHILE AMBULATING WITHIN HIS APARTMENT WHEN THE CANE SUDDENLY BENT CAUSING HIM TO FALL FACE FORWARD ONTO THE FLOOR, RESULTING IN A BRUISE/ CONTUSION TO HIS CHEST AND SHOULDER. ON (B)(6) 2016: GF HEALTH PRODUCTS, INC. RECEIVED WRITTEN DOCUMENTATION ALLEGING THE END-USER HAS A 10% PERMANENT DISABILITY RATING RELATED TO THE (B)(6) 2016 FALL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    637358 LUMEX WALKCANE IPS BLISS HEALTH PRODUCTS CO. LTD 6140A BMR291MO

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Disability