BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROLENE BLUE MONOFILAMENT

    MDR report key: 550309 · Received October 14, 2004

    Report

    Report Number
    MW1033545
    Event Type
    Malfunction
    Date Received
    October 14, 2004
    Date of Event
    September 24, 2004
    Report Date
    September 27, 2004
    Manufacturer
    ETHICON
    Product Code
    DTH
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING A CVOR PROCEDURE THE SURGEON REPORTED REPEATED BREAKAGE OF THE PROLENE SUTURE. BREAKAGE REPORTED WHILE PULLING THROUGH TISSUE AND WHILE TYING OFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROLENE BLUE MONOFILAMENT CARDIOVASCULAR SUTURE DTH ETHICON * SDE377

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other