BEUDAMED
    FDA Adverse Event Death Summary report: N

    SURGIPRO 6/0 24 BLUE CV-1 D/A

    MDR report key: 794791 · Received December 13, 2006

    Report

    Report Number
    2647580-2006-00565
    Event Type
    Death
    Date Received
    December 13, 2006
    Date of Event
    November 7, 2006
    Report Date
    November 13, 2006
    Manufacturer
    PONCE- USS
    Product Code
    GAS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    REPORTEDLY ON MONDAY PT HAD CAROTID ENDARTERECTOMY. PT WAS SENT HOME THE NEXT DAY. THAT NIGHT OR EARLY MORNING THE PATIENT EXPERIENCED A RUPTURE OF THE CAROTID ARTERY. THE PT WAS BROUGHT TO HOSPITAL WHERE HE EXPIRED. NO ADDITIONAL INFORMATION HAS BEEN MADE AVAILABLE. POST MORTEM INFORMATION HAS NOT BEEN RELEASED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SURGIPRO 6/0 24 BLUE CV-1 D/A NON ABSORBABLE SYNTHETIC SUTURE GAS PONCE- USS * UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Death