BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMEGA PORT-SR ACCESS SYSTEM

    MDR report key: 25296 · Received September 8, 1995

    Report

    Report Number
    MW1006869
    Event Type
    Malfunction
    Date Received
    September 8, 1995
    Date of Event
    August 22, 1995
    Report Date
    August 28, 1995
    Manufacturer
    NORFOLK MEDICAL PRODUCTS, INC.
    Product Code
    LJT
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    ID, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THE O-RING FROM PORT INJECTION SITE WAS DEFECTIVE, FELL OFF. A NEW PORT HAD TO BE OPENED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OMEGA PORT-SR ACCESS SYSTEM Implant ACCESS SYSTEM LJT NORFOLK MEDICAL PRODUCTS, INC. OMEGAPORT-SR 7 FRENCH 940801

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR