BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DST SERIES EEA ORVIL 25MM DEVICE

    MDR report key: 2832969 · Received November 5, 2012

    Report

    Report Number
    1219930-2012-00891
    Event Type
    Injury
    Date Received
    November 5, 2012
    Report Date
    October 10, 2012
    Manufacturer
    COVIDIEN, FORMERLY US SURGICAL
    Product Code
    GDW
    PMA / PMN Number
    K062850
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DATE OF INITIAL REPORT SENT: (B)(4) 2012.

    Description of Event or Problem · 1

    PROCEDURE: BARIATRIC PROCEDURE. ACCORDING TO THE REPORTER: THE SURGEON REPORTS THAT THE PT EXPERIENCED A POST OPERATIVE WOUND INFECTION FOLLOWING THE USE OF THE ORVIL PRODUCT. THE PT UNDERWENT AN INCISION AND DRAINAGE PROCEDURE POSTOPERATIVELY TO TREAT THE WOUND INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DST SERIES EEA ORVIL 25MM DEVICE NONE GDW COVIDIEN, FORMERLY US SURGICAL

    Patients

    Seq Age Sex Outcome Treatment
    1 EEA XL 25MM SINGLE-USE STAPLER| EEAXL25