BEUDAMED
    FDA Adverse Event Injury Summary report: N

    *

    MDR report key: 87707 · Received February 9, 1995

    Report

    Report Number
    87707
    Event Type
    Injury
    Date Received
    February 9, 1995
    Date of Event
    December 13, 1994
    Report Date
    December 28, 1994
    Manufacturer
    STRATO MEDICAL CORP
    Product Code
    LJT
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NY, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    REMOVAL OF MALFUNCTIONING VENOUS ACCESS DEVICE, LEFT SIDE. THERE IS A LEAK IN THE TUBING HALF WAY DOWN BETWEEN THE PORT AND THE END OF THE TUBING, 2 PERFORATIONS NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * Implant VENOUS ACCESS DEVICE LJT STRATO MEDICAL CORP * 405912

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Required Intervention