BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OMEGA PORT

    MDR report key: 20548 · Received March 1, 1995

    Report

    Report Number
    20548
    Event Type
    Injury
    Date Received
    March 1, 1995
    Date of Event
    September 15, 1994
    Report Date
    September 23, 1994
    Manufacturer
    NORFOLK MEDICAL
    Product Code
    MDV
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    OBVIOUS LEAK SEEN ON C-ARM IMAGE DURING TEST INFUSION. PORT REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OMEGA PORT SUBCUTANEOUS PORT MDV NORFOLK MEDICAL N/A 200916

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention