BEUDAMED
    FDA Adverse Event Summary report: N

    MOTORIZED 3-WHEELED VEHICLE FOR OUTSIDE TRANSPORT

    MDR report key: 2637580 · Received July 2, 2012

    Report

    Report Number
    1531186-2012-00455
    Date Received
    July 2, 2012
    Date of Event
    June 6, 2012
    Report Date
    June 29, 2012
    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

    (B)(4)-RMA (B)(4) INITIATED FOR THIS ISSUE. MODEL LEO-4S SERIAL NUMBER/DATE CODE (B)(4) IS APPROXIMATELY 1YEAR AND 2 MONTHS OLD. THE OWNER'S MANUAL PART NUMBER 1163141 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 CONSUMERS AGE, HEIGHT AND WEIGHT ARE UNKNOWN. 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 CUSTOMER ALLEGED NO INJURY. THE CUSTOMER ALLEGED MALFUNCTION; THE RIGHT ARM BRACKET RECEIVER HAD A FAULTY WELD. REFERENCE QUOTE NUMBER (B)(4) GIVEN TO BE RETURNED FOR INVACARE INVESTIGATION AND EVALUATION.

    Description of Event or Problem · 1

    CUSTOMER ALLEGED THE R ARM BRACKET RECEIVER HAS A FAULTY WELD. QT #(B)(4). NO 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 Other