BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OHMEGA PORT

    MDR report key: 152939 · Received February 25, 1998

    Report

    Report Number
    MW1013066
    Event Type
    Injury
    Date Received
    February 25, 1998
    Date of Event
    January 15, 1998
    Report Date
    February 24, 1998
    Manufacturer
    NORFOLK MEDICAL PRODUCTS, INC.
    Product Code
    LJT
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OR, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    OHMEGA PORT IMPLANTED 11/26/97. REMOVED 1/15/98 DUE TO SKIN IRRITATION AT SITE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OHMEGA PORT Implant IV ACCESS LJT NORFOLK MEDICAL PRODUCTS, INC. * 970801

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention