BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SCLERO

    MDR report key: 509197 · Received January 27, 2004

    Report

    Report Number
    MW1030940
    Event Type
    Malfunction
    Date Received
    January 27, 2004
    Date of Event
    January 20, 2004
    Report Date
    January 27, 2004
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    FBK
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    SCLEROTHERAPY NEEDLE CAME OUTSIDE OF ITS SHEATH. CAUSED A HOLE IN SCOPE'S BIOPSY CHANNEL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SCLERO SCLERO THERAPY NEEDLE FBK BOSTON SCIENTIFIC MOO518260 80308186

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other