BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DUET TRS 60 4.8MM ARTICULATING SULU

    MDR report key: 1933011 · Received December 10, 2010

    Report

    Report Number
    1219930-2010-00944
    Event Type
    Injury
    Date Received
    December 10, 2010
    Date of Event
    September 10, 2010
    Report Date
    December 7, 2010
    Manufacturer
    UNITED STATES SURGICAL
    Product Code
    GDW
    PMA / PMN Number
    K080898
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE: THORACO/PNEUMOTHORAX. ACCORDING TO THE REPORTER: AFTER SURGERY, THE PT REPORTED PAIN. BLEEDING WAS NOTED. ON (B)(6), RE-OPERATION WAS DONE. IT MIGHT BE CAUSED BY DUET SHEET TOUCHED THE TISSUE. PT CONDITION WAS REPORTED AS OK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DUET TRS 60 4.8MM ARTICULATING SULU DISPOSABLE STAPLER GDW UNITED STATES SURGICAL

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization