BEUDAMED
    FDA Adverse Event Summary report: N

    MOTORIZED 3-WHEELED VEHICLE FOR OUTSIDE TRANSPORT

    MDR report key: 2271296 · Received October 3, 2011

    Report

    Report Number
    1525712-2011-00568
    Date Received
    October 3, 2011
    Report Date
    September 30, 2011
    Manufacturer
    C.T.M. HOMECARE PRODUCT, INC
    Product Code
    INI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    RMA (B)(4) HAS BEEN ISSUED FOR THE RETURN OF THIS SCOOTER. THE AGE OF MODEL LEO-4S SERIAL NUMBER (B)(4) IS UNKNOWN. USER MANUAL PART NUMBER 1163141 REV B (MAY-11) IS THE LATEST REVISION AND WILL BE USED FOR THIS DOCUMENTATION. IT IS UNKNOWN IF THE CONSUMER HAS FULLY READ AND UNDERSTANDS THE LABELING FOR THIS DEVICE. ON PAGE 6 THE FOLLOWING WARNING IS PROVIDED: "WARNING - DO NOT USE THIS PRODUCT OR ANY AVAILABLE OPTIONAL EQUIPMENT WITHOUT FIRST COMPLETELY READING AND UNDERSTANDING THESE INSTRUCTIONS AND ANY ADDITIONAL INSTRUCTIONAL MATERIAL SUCH AS OWNER'S MANUALS, SERVICE MANUALS OR INSTRUCTION SHEETS SUPPLIED WITH THIS PRODUCT OR OPTIONAL EQUIPMENT. IF YOU ARE UNABLE TO UNDERSTAND THE WARNINGS, CAUTIONS OR INSTRUCTIONS, CONTACT A HEALTHCARE PROFESSIONAL, DEALER OR TECHNICAL PERSONNEL BEFORE ATTEMPTING TO USE THIS EQUIPMENT - OTHERWISE, INJURY OR DAMAGE MAY OCCUR. THE CONSUMER'S WEIGHT IS UNKNOWN AND THE LEO-4S HAS A WEIGHT LIMIT OF 350LBS. THE USER MANUAL LEO SCOOTER PART NO. 1163141 STATES ON PAGE 14 THE WEIGHT SPECIFICATION OF 350 LBS WITH A SPECIAL NOTE: "NOTE: WEIGHT LIMITATION IS TOTAL WEIGHT (USER WEIGHT PLUS ANY ADDITIONAL ITEMS THAT THE USER MAY REQUIRE [BACK PACK, ETC.]). EXAMPLE: IF WEIGHT LIMITATION OF THE SCOOTER IS 350 LBS AND ADDITIONAL ITEMS EQUAL 25 LBS, SUBTRACT 25 LBS FROM 350 LBS THIS MEANS THE MAXIMUM WEIGHT LIMITATION OF THE USER IS 325 LBS." IT IS UNKNOWN IF THE CONSUMER WAS USING A BACK PACK, HAULING GROCERIES OR AFFECTING THE LOADING OF THE SCOOTER IN A MANNER THAT COULD CAUSE THE BACK OF THE VAN SEAT TO BREAK WHERE IT MEETS THE BACK.

    Description of Event or Problem · 1

    THE BACK ON THE SCOOTERS ARE ALLEGEDLY BREAKING WHERE THE BACK AND SEAT ATTACH. NO INJURY IS ALLEGED. THIS IS ONE OF THREE COMPLAINTS.

    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 Other