BEUDAMED
    FDA Adverse Event Death Summary report: N

    VASCUFIL 6-0 24" BLUE CV-301 DA

    MDR report key: 339293 · Received June 25, 2001

    Report

    Report Number
    9681850-2001-00009
    Event Type
    Death
    Date Received
    June 25, 2001
    Report Date
    June 8, 2001
    Manufacturer
    THE KENDALL COMPANY (UK) LTD
    Product Code
    GAO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE PRODUCT WAS USED DURING A CABG. REPORTEDLY, ACCORDING TO THE SURGEON FOUR DAYS POST-OPERATIVELY THE SUTURE BROKE ON THE PROXIMAL ANASTOMOSIS. THE PT BLED AND EXPIRED. ADD'L INFO HAS BEEN UNABLE TO BE OBTAINED. CLINICAL SUTURE WAS DISCARDED BY THE HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    28781 VASCUFIL 6-0 24" BLUE CV-301 DA NONABSORBABLE MONOFILAMENT POLYBUTESTER GAO THE KENDALL COMPANY (UK) LTD NA 705858J

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Death