BEUDAMED
    FDA Adverse Event Summary report: N

    MOTORIZED 3-WHEELED VEHICLE FOR OUTSIDE TRANSPORT

    MDR report key: 2960006 · Received February 13, 2013

    Report

    Report Number
    1531186-2013-00593
    Date Received
    February 13, 2013
    Report Date
    February 13, 2013
    Manufacturer
    CHIEN TI ENTERPRISE CO. LTD
    Product Code
    INI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) . ONLY ONE MDR REPORT WILL BE SUBMITTED FOR THIS EVENT, ALTHOUGH TWO DIFFERENT COMPLAINTS WERE CREATED BECAUSE OF DIFFERENT PARTS NEEDED TO REPAIR THE UNIT, AND THE FILE NUMBERS ARE THE FOLLOWING: (B)(4).

    Description of Event or Problem · 1

    (B)(4) - THE DEALER REPORTED THAT THE L-3R SCOOTER TRANSAXLE WAS LEAKING ON THE RIGHT SIDE. THERE WAS NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    62520 MOTORIZED 3-WHEELED VEHICLE FOR OUTSIDE TRANSPORT 890.3800 INI CHIEN TI ENTERPRISE CO. LTD L-3R

    Patients

    Seq Age Sex Outcome Treatment
    1 Other