BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOSYN 4/0 27 VIOLET CV-23

    MDR report key: 1060339 · Received June 13, 2008

    Report

    Report Number
    1219930-2008-00456
    Event Type
    Injury
    Date Received
    June 13, 2008
    Date of Event
    May 20, 2008
    Report Date
    May 22, 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: LAP VIDEO ASSISTED UROLOGICAL PROCEDURE. ACCORDING TO THE REPORTER: WHEN PASSING THE NEEDLE THROUGH THE KIDNEY WITH A NEEDLE-HOLDER, IT WAS NOTICED THAT THE TIP OF THE NEEDLE WAS MISSING (ABOUT 3MM). IT IS UNK IF IT DROPPED INTO THE CAVITY. THE PT WAS X-RAYED BUT THE TIP WAS NOT FOUND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIOSYN 4/0 27 VIOLET CV-23 ABSORBABLE SYNTHETIC SUTURE GAN NORTH HAVEN - USS

    Patients

    Seq Age Sex Outcome Treatment
    1 Other