BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MOTORIZED 3-WHEELED VEHICLE FOR OUTSIDE TRANSPORT

    MDR report key: 2832647 · Received November 14, 2012

    Report

    Report Number
    1525712-2012-02123
    Event Type
    Malfunction
    Date Received
    November 14, 2012
    Date of Event
    October 18, 2012
    Report Date
    November 7, 2012
    Manufacturer
    UNKNOWN
    Product Code
    INI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    (B)(6) - IT WAS REPORTED BY THE CONSUMER THAT THE UNKNOWN SCOOTER MODEL AND SERIAL NUMBERS WAS REPAIRED BY ROAD RUNNER MOBILITY. UPON RETURN FROM REPAIR, IT ALLEGEDLY DID NOT HAVE THE SEAT PROPERLY SECURED TO THE BASE, AND WHEN HER MOTHER WENT DOWN HER RAMP, THE SEAT DISCONNECTED FROM THE BASE, AND THE PATIENT FELL OFF THE SEAT, AND CATCH HERSELF ON THE RAMP RAILS. THE CUSTOMER WAS UNABLE TO FIND ANY IDENTIFYING NUMBERS ON THE SCOOTER TO CONFIRM THE ACCURATE IDENTITY OF THE PRODUCT. ADDITIONALLY, SHE INFORMED THAT IT WAS 10 YEAR OLD. THERE WAS NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MOTORIZED 3-WHEELED VEHICLE FOR OUTSIDE TRANSPORT 890.3800 INI UNKNOWN UNKNOWN SCOOTER

    Patients

    Seq Age Sex Outcome Treatment
    1 80 Other