BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PREMIUM PLUS CEEA 28 INSTR. W/TILT-TOP

    MDR report key: 3131431 · Received May 9, 2013

    Report

    Report Number
    3006451981-2013-00141
    Event Type
    Injury
    Date Received
    May 9, 2013
    Date of Event
    April 8, 2013
    Report Date
    April 17, 2013
    Manufacturer
    COVIDIEN MEDICAL PRODUCTS
    Product Code
    GDW
    PMA / PMN Number
    K001895
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE TYPE: HEMICOLECTOMY. ACCORDING TO THE REPORTER: THE SURGEON PERFORMED ROUTINE END TO SIDE ANASTOMOSIS. PPCEEA 28MM THROUGH COLON TO JOIN TO SMALL BOWEL. ANASTOMOSIS PERFORMED EXTRA-CORPOREALLY AND COLON CLOSED WITH TA. BLEEDING OCCURRED FROM STAPLE LINE. PATIENT REQUIRED 4 UNITS OF BLOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    205070 PREMIUM PLUS CEEA 28 INSTR. W/TILT-TOP DISPOSABLE SURGICAL ACCESSORY GDW COVIDIEN MEDICAL PRODUCTS

    Patients

    Seq Age Sex Outcome Treatment
    1 Other