BEUDAMED
    FDA Adverse Event Injury Summary report: N

    4 WHEELED SCOOTER

    MDR report key: 4020859 · Received August 14, 2014

    Report

    Report Number
    MW5037726
    Event Type
    Injury
    Date Received
    August 14, 2014
    Date of Event
    July 2, 2014
    Report Date
    August 14, 2014
    Product Code
    INI
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TN, US
    Reporter Occupation
    NO INFORMATION

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2014 PATIENT PURCHASED THE 4-WHEELED SCOOTER FROM (B)(6). THEY IN TURN ORDERED IT FROM DRIVE MEDICAL DEVICES AND TECHNOLOGY. THE ORDER WAS FOR A GTA MODEL 4WD. PATIENT ALSO PLACED AN ORDER WITH DRIVE MEDICAL DEVICES AND TECHNOLOGY TO MAKE THE SCOOTER STREET LEGAL BY INCREASING ITS SPEED FROM 9 MPH TO 25 MPH. DIRECT MEDICAL SUPPLIES DELIVERED THE DEVICE. IN PATIENT'S NEIGHBOURHOOD, THE SIDEWALKS ARE ROUGH. WHEN ONE HITS A BUMP, SCOOTER WILL JUMP TO THE LEFT AND TO THE RIGHT RENDERING IT UNCONTROLLABLE. THE ROUGH RIDE CAUSED BY THE POOR DESIGN HAS RE-INJURED HIS SPINE AND RIGHT HIP. HE WOULD LIKE THE FDA TO LOOK INTO THE DESIGN ISSUE. MANUFACTURER NAME: DRIVE MEDICAL DEVICES AND TECHNOLOGY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    487841 4 WHEELED SCOOTER NONE INI BREEZE

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Disability