BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EGIA 60 ARTICULATING MED/THICK SULU

    MDR report key: 2892204 · Received December 21, 2012

    Report

    Report Number
    1219930-2012-01005
    Event Type
    Injury
    Date Received
    December 21, 2012
    Date of Event
    October 11, 2012
    Report Date
    November 27, 2012
    Manufacturer
    COVIDIEN LP, FORMERLY REGISTERED AS UNITED STATES
    Product Code
    GDW
    PMA / PMN Number
    K083519
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE TYPE: LAPAROSCOPIC GASTRIC BYPASS. ACCORDING TO THE REPORTER: STAPLE LINES WERE INSPECTED AND FOUND TO BE HEMOSTATIC ON (B)(6) 2012. ON (B)(6) 2012 THE PATIENT HAD TO BE RETURNED TO THE OPERATING ROOM DUE TO BLEEDING OVER THE STAPLE LINE THAT REQUIRED OVERSEWING. THE PATIENT REQUIRED AN ICU ADMISSION POST-OPERATIVELY AND SUSTAINED A RISE IN CREATINE LIKELY RELATED TO BLOOD LOSS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EGIA 60 ARTICULATING MED/THICK SULU NONE GDW COVIDIEN LP, FORMERLY REGISTERED AS UNITED STATES N2E0753ULX

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Hospitalization| O