BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DURASEAL

    MDR report key: 1613731 · Received February 18, 2010

    Report

    Report Number
    MW5014864
    Event Type
    Malfunction
    Date Received
    February 18, 2010
    Date of Event
    June 18, 2009
    Report Date
    February 18, 2010
    Manufacturer
    COVIDIEN
    Product Code
    NQR
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    DURASEAL SOLUTION FAILED TO MIX.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DURASEAL DURASEAL NQR COVIDIEN 20-2050

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR