BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANGIOSCOPE (DISPOSABLE)

    MDR report key: 586710 · Received March 29, 2005

    Report

    Report Number
    MW1035049
    Event Type
    Malfunction
    Date Received
    March 29, 2005
    Date of Event
    March 3, 2005
    Report Date
    March 29, 2005
    Manufacturer
    EDWARDS LIFE SCIENCE
    Product Code
    LYK
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IL, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    WHITE "PAINT" (DEPTH MARKINGS) FLAKED OFF SCOPE DURING USE. ALL PIECES WERE FLUSHED OUT OF VEIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANGIOSCOPE (DISPOSABLE) * LYK EDWARDS LIFE SCIENCE * JM3F0961

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Other