BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SURGIPRO 7/0

    MDR report key: 1081255 · Received July 23, 2008

    Report

    Report Number
    1219930-2008-00553
    Event Type
    Injury
    Date Received
    July 23, 2008
    Date of Event
    June 10, 2008
    Report Date
    June 30, 2008
    Manufacturer
    NORTH HAVEN - USS
    Product Code
    GAW
    PMA / PMN Number
    K010909
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PROCEDURE: BY-PASS BETWEEN THE SAPHENA AND CORONARY ARTERY. ACCORDING TO THE REPORTER: AT 18 HOURS AFTER THE ORIGINAL SURGERY, THE PT WAS RE-OPERATED ON BECAUSE AN INTERNAL HEMORRHAGE WAS OBSERVED. WHEN THE PT WAS RE-OPENED, THE SURGEON REALIZED THAT THE SUTURE THREAD WAS BROKEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SURGIPRO 7/0 NON-ABSORBABLE SYNTHETIC SUTURE GAW NORTH HAVEN - USS UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Hospitalization| R