BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MOTORIZED 3-WHEELED VEHICLE FOR OUTSIDE TRANSPORT

    MDR report key: 1842919 · Received September 20, 2010

    Report

    Report Number
    1525712-2010-00147
    Event Type
    Injury
    Date Received
    September 20, 2010
    Date of Event
    April 11, 2010
    Report Date
    September 20, 2010
    Manufacturer
    INVACARE
    Product Code
    INI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    USER REPORTEDLY MADE A SHARP TURN IN THEIR SCOOTER AND FELL FROM THEIR SCOOTER, RESULTING IN STITCHES. MFR CONTACTED THE DISTRIBUTOR WHO STATED THEY TRAINED THE USER IN PROPER USE AND PROVIDED A USER MANUAL WHICH COVERS THESE AREAS. NO MALFUNCTION IS APPARENT. DEVICE REMAINS IN USE. MDR FILED BASED ON ALLEGED UNCONFIRMED INJURY.

    Description of Event or Problem · 1

    THE CONSUMER WAS ON THE SCOOTER AND MADE A SHARP TURN AND ALLEGEDLY TURNED OVER, CAUSING HER TO FALL OFF AND CUT HER ARM. THE CONSUMER ALLEGEDLY RECEIVED STITCHES AS A RESULT OF THE ALLEGED INJURY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention