BEUDAMED
    FDA Adverse Event Death Summary report: N

    RIO 3

    MDR report key: 1737912 · Received June 22, 2010

    Report

    Report Number
    MW5016479
    Event Type
    Death
    Date Received
    June 22, 2010
    Date of Event
    June 2, 2010
    Report Date
    June 22, 2010
    Manufacturer
    WU'S TECH CO., LTD
    Product Code
    INI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE EVENT OCCURRED THE EVENING OF (B)(6) 2010. THE PT WAS RIDING THE SCOOTER WHEN THE SCOOTER COLLAPSED AND THREW THE PT OFF. THE PT WAS ADMITTED TO ICU SUFFERING FROM AN APPARENT BLEEDING ON THE BRAIN AND PASSED AWAY ON EITHER (B)(6) 2010 OR (B)(6) 2010. DUE TO THE POSSIBILITY OF LITIGATION, (B)(4), THE DISTRIBUTOR OF THE SCOOTER, HAS NO FURTHER INFO AT THE TIME OF THIS REPORT. THE FAMILY OF THE PT REFUSES TO RELEASE OR DISCLOSE ANY MORE DETAILS ON THIS EVENT. (B)(4) WILL UPDATE FDA WHEN MORE INFO BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RIO 3 3 WHEELED BATTERY OPERATED SCOOTER INI WU'S TECH CO., LTD TRS-2800

    Patients

    Seq Age Sex Outcome Treatment
    1 Death