BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORIGEN CATHETER

    MDR report key: 382303 · Received March 13, 2002

    Report

    Report Number
    1646848-2002-00001
    Event Type
    Malfunction
    Date Received
    March 13, 2002
    Date of Event
    February 11, 2002
    Report Date
    March 8, 2002
    Manufacturer
    ORIGEN BIOMEDICAL, INC.
    Product Code
    DQO
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    USER REPORTED THAT CATHETER HAD A SPOT OF DRIED ADHESIVE ON IT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ORIGEN CATHETER DUAL LUMEN CATHETER DQO ORIGEN BIOMEDICAL, INC. V V 12F 36 G 20154

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN