BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CATH, OMEGA PORT 9.6 FR

    MDR report key: 178372 · Received July 20, 1998

    Report

    Report Number
    178372
    Event Type
    Injury
    Date Received
    July 20, 1998
    Date of Event
    June 22, 1998
    Report Date
    July 2, 1998
    Manufacturer
    NORFOLK MEDICAL PRODUCTS, INC.
    Product Code
    LJT
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT BROUGHT TO OR FOR REMOVAL OF MALFUNCTIONING CHEMOPORT. WHEN PORT CAME OUT, SURGEON NOTED THAT DISTAL END OF CATHETER WAS NOT PRESENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CATH, OMEGA PORT 9.6 FR Implant CHEMOTHERAPY PORT LJT NORFOLK MEDICAL PRODUCTS, INC. P9405 970501

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention