BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OMEGAPORT. SR

    MDR report key: 107506 · Received April 18, 1997

    Report

    Report Number
    MW1011766
    Event Type
    Injury
    Date Received
    April 18, 1997
    Date of Event
    March 25, 1997
    Manufacturer
    NORFOLK MEDICAL PRODUCTS, INC.
    Product Code
    LJT
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    VA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    PT DEVELOPED STAPH SEPTICEMIA REQUIRING RX W/IV ANTIBIOTICS. IMPLANTED PORT FAILED PREMATURELY RESULTING IN LOSS OF USE OF PORT. SEPTUM OF PORT, UPON EXPLANTATION, WAS FOUND TO HAVE SPLIT OPEN IN TWO PLACES RESULTING IN CATASTROPHIC LEAKAGE. PT WAS ADMITTED TO HOSP FOR TREATMENT OF SEPSIS, AND SURGERY TO EXPLANT PORT. MFR, UPON ANALYSIS OF PRODUCT UNABLE TO DETERMINE REASON FOR FISSURES IN PORT AND REFUSES INDEPENDENT EXAM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OMEGAPORT. SR Implant VENOUS ACCESS DEVICE-IMPLANTED PORT LJT NORFOLK MEDICAL PRODUCTS, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Hospitalization| L FOR EVALUATION DESPITE NUMEROUS REQUESTS| MFR REFUSES TO RETURN PRODUCT.