BEUDAMED
    FDA Adverse Event Summary report: N

    MOTORIZED 3-WHEELED VEHICLE FOR OUTSIDE TRANSPORT

    MDR report key: 2647471 · Received July 10, 2012

    Report

    Report Number
    1531186-2012-00502
    Date Received
    July 10, 2012
    Report Date
    July 9, 2012
    Manufacturer
    C.T.M. HOMECARE PRODUCT, INC
    Product Code
    INI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). - RMA (B)(4) HAS BEEN INITIATED FOR THIS ISSUE. MODEL LEO-3B, SERIAL NUMBER/DATE CODE (B)(4) IS APPROXIMATELY 8 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) MALE, (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 DEALER CALLED STATING THAT THE CONSUMER ALLEGEDLY TIPPED OVER 2 TIMES. ONCE WHILE ALLEGEDLY MAKING A TURN AND ONCE WHILE ALLEGEDLY GOING OVER A CURB. THE OWNERS MANUAL STATES A WARNING ON MAKING TURNS ON PAGE 9, "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". IT IS UNKNOWN IF THE CONSUMER WAS WEARING HIS SEAT POSITION STRAP. PAGE 9 OF THE OWNERS MANUAL ALSO WARNS, "ALWAYS WEAR YOUR SEAT POSITIONING STRAP. INASMUCH AS THE SEAT POSITIONING STRAP IS AN OPTION ON THIS SCOOTER (YOU MAY ORDER WITH OR WITHOUT THE SEAT POSITIONING STRAP), INVACARE STRONGLY RECOMMENDS ORDERING THE SEAT POSITIONING STRAP AS AN ADDITIONAL SAFEGUARD FOR THE SCOOTER USER. THE SEAT POSITIONING STRAP IS A POSITIONING STRAP ONLY. IT IS NOT DESIGNED FOR USE AS A SAFETY DEVICE WITHSTANDING HIGH STRESS LOADS SUCH AS AUTO OR AIRCRAFT SAFETY BELTS. IF SIGNS OF WEAR APPEAR, STRAP MUST BE REPLACED IMMEDIATELY". PAGE 11 OF THE OWNER'S MANUAL WARNS IN REGARDS TO CURBS, "DO NOT ATTEMPT TO DRIVE OVER CURBS OR OBSTACLES. DOING SO MAY CAUSE YOUR POWERED SCOOTER TO TURN OVER AND CAUSE BODILY HARM AND/OR DAMAGE TO THE SCOOTER". PAGE 10 OF THE OWNERS MANUAL STATES, "TO ASSURE STABILITY AND PROPER OPERATION OF YOUR POWERED SCOOTER, YOU MUST, AT ALL TIMES, MAINTAIN PROPER BALANCE. YOUR POWERED SCOOTER HAS BEEN DESIGNED TO REMAIN UPRIGHT AND STABLE DURING NORMAL DAILY ACTIVITIES". NO ACTUAL MALFUNCTION OF THE SCOOTER WAS ALLEGED. THE CONSUMER IS UNDER THE WEIGHT LIMITATION OF 350 LBS. FOR THE LEO-3B SCOOTER, REFERENCED IN THE OWNERS MANUAL ON PAGE 14, AS HIS WEIGHT WAS REPORTED AS (B)(6). CONSUMER ALLEGEDLY SUSTAINED A FRACTURED RIGHT HEEL WHEN HE ALLEGEDLY TRIED TO STOP THE SCOOTER FROM TIPPING OVER. THE CONSUMER WAS UNAWARE OF THE INJURY IMMEDIATELY. ACCORDING TO THE CONSUMER, HE ROLLED THE SCOOTER AND DID NOT GET MEDICAL ATTENTION THAT DAY. A FEW DAYS LATER HE WENT TO HIS DOCTOR FOR A ROUTINE VISIT. HE HAS "ISSUES" WITH HIS LEGS. THEY TOOK X-RAYS AND FOUND A FRACTURE HEEL. IT IS UNCLEAR IF THIS INJURY WAS SUSTAINED DIRECTLY FROM THE INCIDENT. HE WAS TOLD TO STAY OFF THE HEEL AND KEEP HIS HEEL ELEVATED. THE DEALER DID CONFIRM THAT THE CONSUMER HAS MORE WEIGHT IN THE MID-REGION AND THIS MAY BE THE LIKELY CAUSE FOR TIPPING. THE CONSUMER HAS A THREE- WHEELED UNIT. TO AVOID THIS FROM HAPPENING IN THE FUTURE, WE OFFERED 4- WHEELED SCOOTER. THE DEALER PROVIDED A SIGNED DOCUMENT IN WHICH THE CONSUMER AGREED TO UPGRADE TO A 4-WHEELED UNIT AND UNDERSTANDS HOW TO PROPERLY USE THE UNIT.

    Description of Event or Problem · 1

    CUSTOMER ALLEGED THE SCOOTER TIPPED OVER AS HE DROVE IT AND MADE A TURN AND ONCE GOING OVER A CURB. MINOR 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-3B

    Patients

    Seq Age Sex Outcome Treatment
    1 47 MO Other