BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RASCAL

    MDR report key: 2101482 · Received May 16, 2011

    Report

    Report Number
    2246975-2011-00001
    Event Type
    Injury
    Date Received
    May 16, 2011
    Date of Event
    June 22, 2010
    Report Date
    May 16, 2011
    Manufacturer
    ELECTRIC MOBILITY CORP.
    Product Code
    INI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ELECTRIC MOBILITY CORP FAILED TO REPORT THIS INCIDENT WITHIN 30 DAYS.

    Description of Event or Problem · 1

    CUSTOMER TIPPED UNIT TURNING A CORNER AND BROKE HER WRIST. REQUIRED HOSPITAL STAY FOR FOUR DAYS. USER ERROR - NO MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RASCAL VEHICLE, 3 WHEELED, MOTORIZED INI ELECTRIC MOBILITY CORP. AUTOGO 555

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Hospitalization