BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GOLDEN COMPASS PRO

    MDR report key: 7112048 · Received December 12, 2017

    Report

    Report Number
    MW5073925
    Event Type
    Injury
    Date Received
    December 12, 2017
    Date of Event
    December 1, 2012
    Report Date
    January 11, 2018
    Manufacturer
    GOLDEN TECHNOLOGIES, INC.
    Product Code
    ITI
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MD, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    CALLER REPORTED HER WHEELCHAIR HAS STOPPED ABRUPTLY IN THE MIDDLE OF THE STREET SEVERAL TIMES, ENDANGERING HER LIFE. THE DEVICE WAS PURCHASED ON (B)(6) 2010 AND WORKED EFFICIENTLY FOR 2 YEARS. THEN IN (B)(6) 2012 THE BATTERY AND WHEELS WERE REPLACED; AFTER THIS DATE THE WHEELCHAIR BEGAN TO MALFUNCTION REGULARLY. SEVERAL TECHS WERE SENT AND REPLACED VARIOUS COMPONENTS OF THE DEVICE BUT THE ISSUE WAS NEVER RESOLVED. CALLER REPORTED INSTEAD OF ALLEVIATING THE MALFUNCTION TECHS WOULD CAUSE MORE ISSUES, I. E., SCREWS AND PINS FALLING. CALLER IS WORRIED FOR HER SAFETY AND IS LOOKING FOR SUPPORT.

    Description of Event or Problem · 1

    ADD'L INFO RECEIVED ON 01/11/2018 FOR REPORT #MW5073925. REPORTER STATES THAT ON (B)(6) 2017 SHE WAS AT THE DENTIST OFFICE; SHE TRIPPED AND FELL AS SHE GOT OUT OF HER WHEELCHAIR. SHE INJURED HER HEAD, SHOULDER AND FRACTURED HER HUMERUS. AS A RESULT, SHE WAS HOSPITALIZED FOR ONE WEEK AND ACQUIRED INFLUENZA, PNEUMONIA AND MISSED RECEIVING TREATMENT AT HER DENTIST APPOINTMENT. REPORTER STATES THAT SHE IS NOT SURE IF THE WHEEL OF THE WHEELCHAIR OR, IF IT WAS THE FOOT REST THAT CAUSED HER TO TRIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    886419 GOLDEN COMPASS PRO POWER WHEELCHAIR ITI GOLDEN TECHNOLOGIES, INC. GP61M-STD-BLU

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Hospitalization| S