BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GOLDEN TECHNOLOGIES

    MDR report key: 3298164 · Received August 15, 2013

    Report

    Report Number
    2523955-2013-00003
    Event Type
    Injury
    Date Received
    August 15, 2013
    Date of Event
    August 11, 2013
    Report Date
    August 15, 2013
    Manufacturer
    GOLDEN TECHNOLOGIES, INC.
    Product Code
    INI
    PMA / PMN Number
    K12258
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    PT WAS ADVISED TO REPLACE HIS CURRENT RAMP WITH A 3" LIP WITH A PROPER RAMP FOR HIS GARAGE WITH A NEAR FLUSH LIP. ALSO WAS ADVISED TO READ OWNERS MANUAL INSTRUCTIONS ON CURBS AND RAMPS. INITIAL REPORTER IS END USER. HIPPA DOES NOT ALLOW ME TO FILL OUT HIS NAME ON THIS REPORT.

    Description of Event or Problem · 1

    END USER STATED THAT HE TRIED TO DRIVE UP A RAMP WITH A 3" LIP. WHEN FRONT TIRE HIT 3" LIP, THE SCOOTER FRONT WHEEL WAS PROPELLED INTO THE AIR CAUSING THE SCOOTER TO FLIP OVER ON TOP OF USER. USER CUT HIS HEAD ON THE FLOOR AND NEEDED 3 STITCHES TO CLOSE THE CUT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    393722 GOLDEN TECHNOLOGIES VEHICLE MOTORIZED 3-WHEELED INI GOLDEN TECHNOLOGIES, INC. GC340

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Required Intervention