BEUDAMED
    FDA Adverse Event Summary report: N

    MOTORIZED 3-WHEELED VEHICLE FOR OUTSIDE TRANSPORT

    MDR report key: 3218093 · Received July 10, 2013

    Report

    Report Number
    1531186-2013-03100
    Date Received
    July 10, 2013
    Report Date
    June 19, 2013
    Manufacturer
    C.T.M. HOMECARE PRODUCT, INC
    Product Code
    INI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). - FOLLOW UP #001. INITIAL PR (B)(4) ISSUED MFR. REPORT # 1531186-2013-03100 INDICTING THE BRAND NAME AS A POWERED WHEELCHAIR, THE COMMON DEVICE NAME AS 890.3860 AND THE TYPE OF DEVICE AS ITI. THE CORRECT BRAND NAME IS MOTORIZED 3-WHEELED VEHICLE FOR OUTSIDE TRANSPORT, THE COMMON DEVICE NAME IS 890.3800 AND THE TYPE OF DEVICE IS INI. SUSPECT MEDICAL DEVICE TAB: HAVE BEEN CORRECTED.

    Description of Event or Problem · 1

    PROVIDER STATES BAD WIRING HARNESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    315186 MOTORIZED 3-WHEELED VEHICLE FOR OUTSIDE TRANSPORT 890.3800 INI C.T.M. HOMECARE PRODUCT, INC L-4B

    Patients

    Seq Age Sex Outcome Treatment
    1 Other