BEUDAMED
    FDA Adverse Event Summary report: N

    MOTORIZED 3-WHEELED VEHICLE FOR OUTSIDE TRANSPORT

    MDR report key: 2309670 · Received October 26, 2011

    Report

    Report Number
    1525712-2011-00646
    Date Received
    October 26, 2011
    Date of Event
    September 28, 2011
    Report Date
    October 26, 2011
    Manufacturer
    UNKNOWN
    Product Code
    INI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    NO RMA HAS BEEN INITIATED FOR THIS ISSUE. MODEL LYNX L-3 SCOOTER SERIAL NUMBER/DATE CODE UNKNOWN HAS AN UNKNOWN AGE. THE USER MANUAL PART NUMBER 1163141 REV B (MAY-11) WAS ISSUED WITH THIS DEVICE. IT IS UNKNOWN IF THE CONSUMER HAS FULLY READ AND UNDERSTANDS THE USER MANUAL. DOCUMENTATION PROVIDES WARNINGS, CAUTIONS, AND INSTRUCTIONS FOR SAFELY USING THE DEVICE. IF THE CONSUMER DOES NOT UNDERSTAND THE WRITTEN WARNINGS, CAUTIONS OR INSTRUCTIONS THEN THEY SHOULD CONTACT INVACARE. THE CONSUMERS MEDICAL CONDITION, STABILITY AND MEDICATION REGIMEN ARE UNKNOWN . THE CONSUMERS AGE, HEIGHT AND WEIGHT ARE UNKNOWN. THE CONSUMERS TECHNIQUE WHILE USING THE DEVICE IS UNKNOWN. THE MAINTENANCE HISTORY OF THE DEVICE IS UNKNOWN.

    Description of Event or Problem · 1

    AS CONSUMER WAS GOING UP RAMP, SCOOTER STALLED AND GOT STUCK. WHEN SHE TRIED TO REVERSE, SCOOTER ALLEGEDLY FLIPPED OVER BACKWARDS CAUSING HER TO FALL AND HIT PAVEMENT. SERIOUS INJURY IS ALLEGED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 61 Other