BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ILLUMEN 8

    MDR report key: 93594 · Received May 22, 1997

    Report

    Report Number
    1217435-1997-00168
    Event Type
    Malfunction
    Date Received
    May 22, 1997
    Date of Event
    April 22, 1997
    Report Date
    April 30, 1997
    Manufacturer
    USCI DIV C.R. BARD, INC.
    Product Code
    LIT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING THE PROCEDURE THIS DEVICE LEAKED. REPORTEDLY, THE LEAK OCCURRED A FEW MILLIMETERS FROM THE HUB. THE DEVICE WAS REMOVED AND REPLACED. THERE IS NO REPORT OF PT INJURY. THE DEVICE IS BEING RETURNED FOR CO'S ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ILLUMEN 8 ANGIOPLASTY CATHETER LIT USCI DIV C.R. BARD, INC. NA 08JG0373

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN