BEUDAMED
    FDA Adverse Event Injury Summary report: N

    4 WHEEL SCOOTER

    MDR report key: 12354143 · Received August 20, 2021

    Report

    Report Number
    MW5103416
    Event Type
    Injury
    Date Received
    August 20, 2021
    Date of Event
    August 19, 2021
    Report Date
    August 20, 2021
    Manufacturer
    GOLDEN TECHNOLOGIES, INC. / GOLDEN BROTHERS, INC.
    Product Code
    INI
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IN
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 1

    CALLER STATED EARLY THIS YEAR WHEN HE PUSHED HIS 4-WHEEL SCOOTER TO GO FORWARD IT GETS A CLICKING SOUND AND THEN THE SCOOTER GOES INTO FULL REVERSE. HE TRIED STOPPING IT ON THIS DAY USING THE PADDLE CONTROL BUT IT DID NOT STOP. HE CONTACTED THE MANUFACTURER AND WAS ASKED TO RETURN THE DEVICE FOR REPAIRS. AFTER THREE WITH THE MANUFACTURER THE SCOOTER WAS RETURNED BACK TO THE CALLER BUT THE PROBLEM PERSIST. A NEW CONTROLLER AND PADDLE WAS SENT TO THE CALLER AND INSTALLED INTO THE SCOOTER, BUT THE SCOOTER STILL DID NOT WORK CORRECTLY. YESTERDAY (B)(6) 2021 CALLER STATED THAT HE WAS DRIVING THE SCOOTER AND THE SAME PROBLEM HAPPENED BUT THIS TIME HE WAS THROWN OFF THE SCOOTER WHERE HE SUSTAINED INJURIES ALL OVER HIS BODY AND EXPERIENCED PAIN. THE SCOOTER IS NOW DAMAGED THAT HE COULD NOT TURN IT TO THE LEFT OR RIGHT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1243698 4 WHEEL SCOOTER VEHICLE, MOTORIZED 3-WHEELED INI GOLDEN TECHNOLOGIES, INC. / GOLDEN BROTHERS, INC. GA541

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention