BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VENOUS ACCESS DEVICE

    MDR report key: 87690 · Received February 9, 1995

    Report

    Report Number
    87690
    Event Type
    Injury
    Date Received
    February 9, 1995
    Date of Event
    October 12, 1994
    Report Date
    November 4, 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

    MALFUNCTIONING VENOUS ACCESS DEVICE. TWO CM FROM RESERVOIR THERE IS A BALLOONING DEFECT, SECTION IS 6MM IN DIAMETER, REST OF THE TUBING IS 3MM IN DIAMETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VENOUS ACCESS DEVICE Implant * LJT STRATO MEDICAL CORP * 402504

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Required Intervention