BEUDAMED
    FDA Adverse Event Summary report: N

    MOTORIZED 3-WHEELED VEHICLE FOR OUTSIDE TRANSPORT

    MDR report key: 2832761 · Received November 14, 2012

    Report

    Report Number
    1531186-2012-01376
    Date Received
    November 14, 2012
    Report Date
    November 8, 2012
    Manufacturer
    C.T.M. HOMECARE PRODUCT, INC
    Product Code
    INI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    (B)(4) - THE DEALER REPORTED THAT THE L-3XR SCOOTER WAS NOT CHANGING SPEED DUE TO A MALFUNCTIONING POTENTIOMETER. THERE WAS NO REPORTED PATIENT INJURY.

    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 L-3XR

    Patients

    Seq Age Sex Outcome Treatment
    1 Other