BEUDAMED
    FDA Adverse Event Death Summary report: N

    SURGIPRO 7-0 CV-1 5X24" OPTIVIS DA

    MDR report key: 476741 · Received August 8, 2003

    Report

    Report Number
    476741
    Event Type
    Death
    Date Received
    August 8, 2003
    Date of Event
    July 18, 2002
    Report Date
    July 11, 2003
    Manufacturer
    US SURGICAL
    Product Code
    GAO
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    IN 2002 THE PT UNDERWENT A CABG AND WAS DISCHARGED 5 DAYS LATER. THE PT WAS READMITTED 2 DAYS LATER AFTER A SYNCOPAL EPISODE AT HOME, EVALUATED BY CARDIOLOGY, AND DISCHARGED THE FOLLOWING DAY. THE PT EXPIRED AT HOME ONE DAY LATER. THE CORONER'S REPORT NOTES A FAILURE OF THE SUTURE AT THE GRAFT SITE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SURGIPRO 7-0 CV-1 5X24" OPTIVIS DA SUTURE GAO US SURGICAL * *

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Death