BEUDAMED
    FDA Adverse Event Summary report: N

    MOTORIZED 3-WHEELED VEHICLE FOR OUTSIDE TRANSPORT

    MDR report key: 2880609 · Received December 19, 2012

    Report

    Report Number
    1531186-2012-01831
    Date Received
    December 19, 2012
    Report Date
    December 19, 2012
    Manufacturer
    C.T.M. HOMECARE PRODUCT, INC
    Product Code
    INI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    MDR DECISION DATE: (B)(6). NO SERIOUS INJURY ALLEGED. MALFUNCTION ALLEGED. DEALER/CONSUMER CLAIM UNIT STOPS AND WHEN THEY WIGGLE THE TILLER IT WILL START BACK UP. DEALER COULD NOT DUPLICATE THE PROBLEM WHEN TEST DROVE. MDR FILED.

    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-4R

    Patients

    Seq Age Sex Outcome Treatment
    1 Other