BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN EEA

    MDR report key: 2782098 · Received October 3, 2012

    Report

    Report Number
    2647580-2012-00632
    Event Type
    Injury
    Date Received
    October 3, 2012
    Report Date
    September 4, 2012
    Manufacturer
    COVIDIEN, FORMERLY USSC PUERTO RICO
    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: THE SURGEON INFORMED THE SALES REP THAT THE PATIENT RETURNED TO THE O.R. WITH AN ANTERIOR ANASTOMOTIC LEAK. THE PATIENTS HAD A WASHOUT AND A DIVERSION. FURTHER DETAILS COULD NOT BE OBTAINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN EEA DISPOSABLE STAPLER GDW COVIDIEN, FORMERLY USSC PUERTO RICO

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R