BEUDAMED
    FDA Adverse Event Death Summary report: N

    USSC SURGIPRO

    MDR report key: 70742 · Received February 14, 1997

    Report

    Report Number
    1219161-1997-00149
    Event Type
    Death
    Date Received
    February 14, 1997
    Date of Event
    January 11, 1997
    Report Date
    January 15, 1997
    Manufacturer
    UNITED STATES SURGICAL CORP.
    Product Code
    GAW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE DEVICE WAS USED DURING A CABG PROCEDURE. REPORTEDLY, THE PT BEGAN BLEEDING PROFUSELY FROM ONE OF THE SUTER LINES. THE PT SUFFERED SEVERE BLOOD AND REQUIRED BLOOD TRANSFUSION. THE PT EXPIRED DUE TO TRANSFUSION SHOCK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 USSC SURGIPRO Implant MONOFILAMENT POLYPROPYLENE SUTURE GAW UNITED STATES SURGICAL CORP. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Death