BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STRATO MEDICAL

    MDR report key: 83864 · Received January 31, 1995

    Report

    Report Number
    83864
    Event Type
    Injury
    Date Received
    January 31, 1995
    Date of Event
    December 19, 1994
    Report Date
    December 30, 1994
    Manufacturer
    STRATO MEDICAL CORP.
    Product Code
    LJT
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    GA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    CATHETER MALFUNCTIONING. WHEN CATHETER REMOVED IT WAS FOUND TO BE SEPARATED IN TWO PARTS. DISTAL PORTION OF CATHETER HAD TO BE REMOVED UNDER FLUOROSCOPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STRATO MEDICAL Implant INFUSA PORT LJT STRATO MEDICAL CORP. 5513 *

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention