BEUDAMED
    FDA Adverse Event Death Summary report: N

    PROLENE POLYPROPYLENE SUTURE

    MDR report key: 4201893 · Received September 30, 2014

    Report

    Report Number
    4201893
    Event Type
    Death
    Date Received
    September 30, 2014
    Date of Event
    February 26, 2014
    Report Date
    September 30, 2014
    Manufacturer
    ETHICON, INC.
    Product Code
    GAW
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    WI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PATIENT HAD A CAROTID ENDARTERECTOMY EARLIET THIS YEAR. CAME IN THROUGH ED AND SUSPECT DISRUPTED GRAFT. NO AUTOPSY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    608004 PROLENE POLYPROPYLENE SUTURE SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE GAW ETHICON, INC. 8805H *

    Patients

    Seq Age Sex Outcome Treatment
    1 * Death NO OTHER THERAPIES