BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PREMIUM SURGICLIP S-9.0 TITANIUM

    MDR report key: 1445473 · Received August 19, 2009

    Report

    Report Number
    2647580-2009-00440
    Event Type
    Injury
    Date Received
    August 19, 2009
    Date of Event
    July 29, 2009
    Report Date
    August 3, 2009
    Manufacturer
    PONCE - USS
    Product Code
    GDO
    PMA / PMN Number
    K853650
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF INITIAL REPORT: 08/17/2009.

    Description of Event or Problem · 1

    PROCEDURE: ACCORDING TO THE REPORTER: THE DEVICE HANDLE JAMMED AND SURGEON HAD TO PRY IT OPEN. THE VEIN GOT CUT AND WAS SUTURED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PREMIUM SURGICLIP S-9.0 TITANIUM NONE GDO PONCE - USS

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Other