BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOSUTURE VERSASEAL

    MDR report key: 2223049 · Received August 19, 2011

    Report

    Report Number
    MW5021843
    Event Type
    Malfunction
    Date Received
    August 19, 2011
    Date of Event
    July 1, 2011
    Report Date
    August 12, 2011
    Manufacturer
    UNITED STATES SURGICAL
    Product Code
    GCJ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NC, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THERE IS A FOREIGN OBJECT (POSSIBLY AN INSECT) INSIDE THE PACKAGING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AUTOSUTURE VERSASEAL 5MM SEAL GCJ UNITED STATES SURGICAL 175770 P1B1111

    Patients

    Seq Age Sex Outcome Treatment
    1