BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VAXCEL PORT

    MDR report key: 1577493 · Received January 4, 2010

    Report

    Report Number
    MW5014276
    Event Type
    Injury
    Date Received
    January 4, 2010
    Date of Event
    September 18, 2009
    Report Date
    January 2, 2010
    Manufacturer
    NAVILYST MEDICAL INC
    Product Code
    LJT
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    PARTIAL RUPTURE OF PORTACATH (LEFT SUBCLAVIAN) DIAGNOSED BY PORTOGRAM IN 2009 (COULD HAVE BROKEN OFF DURING CHEMOTHERAPY). WAS TO HAVE LASTED AS LONG AS I NEED IT. NOW I'M AFRAID TO HAVE ANOTHER CATHETER INSERTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VAXCEL PORT PORTACATH LJT NAVILYST MEDICAL INC 1317254

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Life Threatening| R