BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PREMIUM PLUS CEEA 25 INSTR. W/TILT-TOP

    MDR report key: 1041165 · Received May 12, 2008

    Report

    Report Number
    2647580-2008-00274
    Event Type
    Injury
    Date Received
    May 12, 2008
    Date of Event
    September 24, 2007
    Report Date
    April 18, 2008
    Manufacturer
    PONCE - USS
    Product Code
    GDW
    PMA / PMN Number
    K062850
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PROCEDURE TYPE: LAP GASTRIC BYPASS. PATIENT: FEMALE. ACCORDING TO THE REPORTER: THERE WERE NO INTRA-OPERATIVE COMPLICATIONS; HOWEVER, A SEVERE POST-OPERATIVE STENOSIS WAS NOTED IN LATE 2007. THE STENOSIS WAS SUCCESSFULLY CORRECTED WITH AN ESOPHAGEAL BALLOON DILATOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PREMIUM PLUS CEEA 25 INSTR. W/TILT-TOP DISPOSABLE SURGICAL STAPLER GDW PONCE - USS P6L752J

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Hospitalization| R