BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN EEA

    MDR report key: 3894044 · Received June 18, 2014

    Report

    Report Number
    2647580-2014-00453
    Event Type
    Injury
    Date Received
    June 18, 2014
    Date of Event
    May 19, 2014
    Report Date
    June 9, 2014
    Manufacturer
    COVIDIEN, FORMERLY USSC
    Product Code
    GDW
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE TYPE: SIGMOID RESECTION. ACCORDING TO THE REPORTER: AFTER TWO WEEKS POSTOPERATIVE, A SMALL ANASTOMOTIC LEAK WAS DISCOVERED AFTER THE PATIENT REPORTED ABDOMINAL PAIN. PATIENT WAS READMITTED INTO THE HOSPITAL. IT IS UNKNOWN WHETHER THE PAIN IS RELATED TO AN INCISION INFECTION OR THE LEAK. THE LEAK WAS ASYMPTOMATIC. ANTIBIOTICS WERE USED TO TREAT THE PROBLEM. THERE WAS NO UNANTICIPATED TISSUE LOSS. THERE WAS NO UNANTICIPATED BLOOD LOSS OF MORE THAN 500CC. THERE WAS NO DELAY OVER 30 MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    358922 UNKNOWN EEA DISPOSABLE SURGICAL STAPLER GDW COVIDIEN, FORMERLY USSC UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other