BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GIA 60-3.8 SINGLE USE LOADING UNIT

    MDR report key: 1033781 · Received April 25, 2008

    Report

    Report Number
    2647580-2008-00243
    Event Type
    Injury
    Date Received
    April 25, 2008
    Report Date
    March 31, 2008
    Manufacturer
    PONCE - USS
    Product Code
    GDW
    PMA / PMN Number
    K013860
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    INITIAL REPORT SENT: 04/25/2008.

    Description of Event or Problem · 1

    PROCEDURE TYPE: UNKNOWN. ACCORDING TO THE REPORTER: THERE WAS A POST-OPERATIVE LEAK AT THE STAPLE LINE. NO OTHER INFORMATION WAS PROVIDED FROM THE ACCOUNT ABOUT THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GIA 60-3.8 SINGLE USE LOADING UNIT DISPOSABLE SURGICAL STAPLER GDW PONCE - USS UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention