BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GOLDEN LITEWAY

    MDR report key: 3204316 · Received July 1, 2013

    Report

    Report Number
    2523955-2013-00002
    Event Type
    Injury
    Date Received
    July 1, 2013
    Date of Event
    March 20, 2013
    Report Date
    June 24, 2013
    Manufacturer
    GOLDEN TECHNOLOGIES, INC.
    Product Code
    INI
    PMA / PMN Number
    K063162
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    UNABLE TO EVALUATE THE SCOOTER FOR THE FOLLOWING REASONS: END USER WILL NOT RETURN PHONE CALLS. DEALER WHERE PURCHASED IS NOW OUT OF BUSINESS.

    Description of Event or Problem · 1

    USER SAID THAT HE WAS GOING DOWN A RAMP AND SOMETHING CAUSED THE SCOOTER TO FLIP OVER. USER FELL ONTO THE BLACKTOP PARKING LOT AND CLAIMS THAT HE BROKE HIS HIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    298921 GOLDEN LITEWAY SCOOTER 3 WHEELED INI GOLDEN TECHNOLOGIES, INC. GL100

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Hospitalization