BEUDAMED
    FDA Adverse Event Summary report: N

    MOTORIZED 3-WHEELED VEHICLE FOR OUTSIDE TRANSPORT

    MDR report key: 2726957 · Received September 5, 2012

    Report

    Report Number
    1531186-2012-00807
    Date Received
    September 5, 2012
    Report Date
    August 30, 2012
    Manufacturer
    C.T.M. HOMECARE PRODUCT, INC
    Product Code
    INI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) - NO RMA HAS BEEN INITIATED FOR THIS ISSUE. MODEL L-3B, SERIAL NUMBER/DATE CODE AND AGE OF PRODUCT ARE UNKNOWN. THE OWNER'S MANUAL PART NUMBER 1143205 WAS ISSUED WITH THIS DEVICE. THE OWNER'S MANUAL IS ALSO FOUND ON-LINE AT INVACARE.COM. IT IS UNKNOWN IF THE CONSUMER HAS FULLY READ AND UNDERSTANDS THE OWNER'S 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 CONSUMER IS A (B)(6) FEMALE WHO WEIGHS (B)(6). THE CONSUMERS MEDICAL CONDITION, STABILITY AND MEDICATION REGIMEN ARE UNKNOWN. THE CONSUMERS TECHNIQUE WHILE USING THE DEVICE IS UNKNOWN. THE MAINTENANCE HISTORY OF THE DEVICE IS UNKNOWN. THE CONSUMER CALLED STATING THAT THE LEO L-3B SCOOTER ALLEGEDLY LOCKS WHEN SHE IS MAKING A SHARP TURN OR GOING BACKWARDS. SHE ALSO STATES THAT ELEVATOR DOORS ARE CLOSING ON HER AND STATES THAT THE SCOOTER IS VERY CHALLENGING FOR HER. THE OWNER'S MANUAL STATES THE FOLLOWING WARNINGS, PAGE 9 STATES, "DO NOT MAKE SHARP TURNS IN THE FORWARD OR REVERSE DIRECTION AT EXCESSIVE SPEED. FAILURE TO OBSERVE THE WARNING CAN CAUSE THE SCOOTER TO TIP OVER AND MAY RESULT IN INJURY TO USER AND/OR DAMAGE TO THE PRODUCT." THE CONSUMER'S WEIGHT IS REPORTED AT (B)(6). THE OWNERS MANUAL STATES ON PAGE 14, "WARNING - THE WEIGHT LIMITATION IS (B)(6)." THE CONSUMER IS OVER THE LIMITATION BY (B)(6). THE MALFUNCTION HAS NOT BEEN CONFIRMED.

    Description of Event or Problem · 1

    CONSUMER CALLED STATING THAT THE L-3B SCOOTER ALLEGEDLY LOCKS WHEN SHE MAKES SHARP TURNS AND WHEN GOING IN REVERSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MOTORIZED 3-WHEELED VEHICLE FOR OUTSIDE TRANSPORT 890.3800 INI C.T.M. HOMECARE PRODUCT, INC L-3B

    Patients

    Seq Age Sex Outcome Treatment
    1 52 Other