BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PREMIUM PLUS CEEA 28 INSTR. W/TILT-TOP

    MDR report key: 2953953 · Received February 6, 2013

    Report

    Report Number
    2647580-2013-00061
    Event Type
    Injury
    Date Received
    February 6, 2013
    Report Date
    January 9, 2013
    Manufacturer
    COVIDIEN, FORMERLY USSC PUERTO RICO
    Product Code
    GDW
    PMA / PMN Number
    K001895
    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

    ACCORDING TO THE REPORTER: THE SURGEON STATES HE HAS EXPERIENCED LEAKS AND INCOMPLETE STAPLE LINES WITHOUT SUPPLYING SPECIFIC CASES INVOLVED, A SPECIFIC STAPLER SIZE. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND THE CUSTOMER STATES THAT FURTHER INFORMATION WILL NOT BE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    49681 PREMIUM PLUS CEEA 28 INSTR. W/TILT-TOP DISPOSABLE SURGICAL STAPLING DEVICE GDW COVIDIEN, FORMERLY USSC PUERTO RICO P0G1054J

    Patients

    Seq Age Sex Outcome Treatment
    1 Other