BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VITAL-PORT

    MDR report key: 49919 · Received November 13, 1996

    Report

    Report Number
    2522007-1996-00006
    Event Type
    Injury
    Date Received
    November 13, 1996
    Date of Event
    October 2, 1996
    Report Date
    October 17, 1996
    Manufacturer
    COOK PACEMAKER CORP.
    Product Code
    LJT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE INFO RECEIVED FROM THE DISTRIBUTOR STATED: "THE PORT HAS BEEN REMOVED BECAUSE DURING THE THERAPY THEY FOUND OUT THAT THE CATHETER WAS BROKEN IN THE POINT WHERE THE CATHETER GO THROUGH THE COLLARBONE AND THE FIRST RIB."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VITAL-PORT Implant VASCULAR ACCESS SYSTEM LJT COOK PACEMAKER CORP. 7112V 18135

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Required Intervention