BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EEA 31MM SINGLE-USE STAPLER

    MDR report key: 1910471 · Received November 24, 2010

    Report

    Report Number
    1219930-2010-00893
    Event Type
    Injury
    Date Received
    November 24, 2010
    Report Date
    November 1, 2010
    Manufacturer
    UNITED STATES SURGICAL
    Product Code
    GDW
    PMA / PMN Number
    K062850
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER: POST OPERATIVELY BLEEDING AT THE STAPLE LINE OCCURRED. THIS CAUSED THE PT TO STAY IN THE HOSPITAL LONGER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EEA 31MM SINGLE-USE STAPLER DISPOSABLE STAPLER GDW UNITED STATES SURGICAL N0E0507UHQ

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization