BEUDAMED
    FDA Adverse Event Summary report: N

    MOTORIZED 3-WHEELED VEHICLE FOR OUTSIDE TRANSPORT

    MDR report key: 2526416 · Received April 11, 2012

    Report

    Report Number
    1531186-2012-00125
    Date Received
    April 11, 2012
    Date of Event
    March 11, 2012
    Report Date
    April 10, 2012
    Manufacturer
    C.T.M. HOMECARE PRODUCT, INC
    Product Code
    INI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    RMA (B)(4) HAS BEEN INITIATED FOR THIS ISSUE. MODEL LEO-4S, (B)(4) IS APPROXIMATELY 3 MONTHS OLD. THE OWNER'S MANUAL PART NUMBER 1163141 REV B (MAY-11) 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, (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 HAS HAD THE DEVICE FOR 2 MONTHS. THE DEALER STATED THAT THE CONSUMER WAS RIDING HER SCOOTER AND THE STEERING LOCKED UP WHEN THE CONSUMER MADE A RIGHT TURN, THUS CAUSING HER TO HIT A CURB. THE IMPACT TO THE CURB ALLEGEDLY CAUSED THE SHROUD TO CRACK ON THE RIGHT SIDE AND CAUSED UNDETERMINED BODILY INJURY. NO MEDICAL INTERVENTION WAS SOUGHT. THE DEALER STATED THAT ONE OF THE DEALERSHIP OWNERS SAT ON THE SCOOTER AND THE STEERING LOCKED UP FOR HER ALSO. IT IS UNKNOWN IF THE CONSUMER WAS RIDING THE SCOOTER IN THE STREET, IN ORDER TO HIT A CURB. THE OWNER'S MANUAL STATES A WARNING, ON PAGE 7, "DO NOT OPERATE ON ROADS, STREETS OR HIGHWAYS". PAGE 9 ALSO STATES A WARNING, "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". AN RMA HAS BEEN ISSUED AND THE DEVICE IS TO BE RETURNED FOR AN EVALUATION.

    Description of Event or Problem · 1

    CUSTOMER ALLEGED THE STEERING LOCKED UP AND ALLEGED THE WELD ON THE PINS UNDER THE CARRIAGE THAT RESTRICT THE TURNING ARE SEPARATED. UNDETERMINED INJURY ALLEGED.

    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 LEO-4S

    Patients

    Seq Age Sex Outcome Treatment
    1 48 MO Other