BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMEGAPORT

    MDR report key: 86657 · Received April 13, 1997

    Report

    Report Number
    1450392-1997-90001
    Event Type
    Malfunction
    Date Received
    April 13, 1997
    Report Date
    April 18, 1997
    Manufacturer
    NORFOLK MEDICAL PRODUCTS, INC.
    Product Code
    LJT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    PT CALLED CO & STATED THAT HER "PORT" WAS RECENTLY EXPLANTED AND THAT SHE SUSPECTED IT WAS LEAKING. SHE REQUESTED THAT THE DEVICE BE ANALYZED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OMEGAPORT DRUG DELIVERY DEPOT LJT NORFOLK MEDICAL PRODUCTS, INC. NA 94801

    Patients

    Seq Age Sex Outcome Treatment
    1 *