BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOSYN 4/0

    MDR report key: 1083288 · Received July 28, 2008

    Report

    Report Number
    1219930-2008-00567
    Event Type
    Injury
    Date Received
    July 28, 2008
    Date of Event
    June 27, 2008
    Report Date
    July 1, 2008
    Manufacturer
    NORTH HAVEN - USS
    Product Code
    GAN
    PMA / PMN Number
    K000037
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PROCEDURE TYPE: END TO END ANASTOMOSIS. ACCORDING TO THE REPORTER: DURING THE PROCEDURE, THE NEEDLE BROKE EASILY. THE PROCEDURE WAS EXTENDED MORE THAN 30 MINUTES TO FIND AND RETRIEVE THE NEEDLE TIP FROM THE CAVITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIOSYN 4/0 SYNTHETIC ABSORBABLE SUTURE GAN NORTH HAVEN - USS A8A1295

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization