BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PREMIUM SURGICLIP S-9.0 TITANIUM

    MDR report key: 2953926 · Received February 6, 2013

    Report

    Report Number
    2647580-2013-00066
    Event Type
    Injury
    Date Received
    February 6, 2013
    Date of Event
    December 20, 2012
    Report Date
    January 16, 2013
    Manufacturer
    COVIDIEN, FORMERLY USSC PUERTO RICO
    Product Code
    FZP
    PMA / PMN Number
    K853650
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4)

    Description of Event or Problem · 1

    PROCEDURE: FEM POP. ACCORDING TO THE REPORTER: THE CLIP CUT THE TISSUE. THERE WAS NO UNINTENDED COLOSTOMY, FORMAL LAP, AND RE-OPERATIONS. THERE WAS NO UNANTICIPATED TISSUE LOSS. THE INCISION WAS NOT EXTENDED BY MORE THAN ONE INCH. THERE WAS NO BLEEDING REPORTED IN EXCESS OF 250CC. NO DEVICE FRAGMENT OR COMPONENT FELL INTO THE PATIENT'S CAVITY. THERE WAS NO DEVICE FRAGMENT OR COMPONENT WAS LEFT IN THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    49570 PREMIUM SURGICLIP S-9.0 TITANIUM DISPOSABLE CLIP APPLIER FZP COVIDIEN, FORMERLY USSC PUERTO RICO

    Patients

    Seq Age Sex Outcome Treatment
    1