BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIFEPORT VASCULAR ACCESS SYSTEM

    MDR report key: 85208 · Received July 3, 1996

    Report

    Report Number
    85208
    Event Type
    Injury
    Date Received
    July 3, 1996
    Date of Event
    May 21, 1996
    Report Date
    May 29, 1996
    Manufacturer
    STRATO-INFUSAID, INC.
    Product Code
    LJT
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    SC, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    CATHETER INSERTED ON 4/29/96-ON 5/21/96 MD REMOVED DUE TO INFLAMED LEFT BREAST AND SURROUNDING TISSUE UPON EXAMINATION, CATH APPEARED TO HAVE A PIN-HOLE IN IT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFEPORT VASCULAR ACCESS SYSTEM Implant PORT-A-CATH LJT STRATO-INFUSAID, INC. * 12822

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention