BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EEA XL 25MM SINGLE USE STAPLER WITH

    MDR report key: 1030057 · Received April 15, 2008

    Report

    Report Number
    1219930-2008-00286
    Event Type
    Injury
    Date Received
    April 15, 2008
    Date of Event
    November 27, 2007
    Report Date
    March 24, 2008
    Manufacturer
    NORTH HAVEN - USS
    Product Code
    GDW
    PMA / PMN Number
    K062850
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INITIAL REPORT SENT: 04/10/2008.

    Description of Event or Problem · 1

    PROCEDURE TYPE: LAP GASTRIC BYPASS. ACCORDING TO THE REPORTER: NO INTRA-OPERATIVE COMPLICATIONS WERE REPORTED. POST OPERATIVELY, GI BLEEDING WAS NOTED. THE PATIENT WAS GIVEN A BLOOD TRANSFUSION 1800CC, AND IV FLUIDS. NO OTHER ABNORMALITIES (STRICTURE, LEAK) WERE OBSERVED. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL IN 2007.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EEA XL 25MM SINGLE USE STAPLER WITH DISPOSABLE SURGICAL STAPLER GDW NORTH HAVEN - USS V6L02R

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Required Intervention