BEUDAMED
    FDA Adverse Event Injury Summary report: N

    V-LOC 180 ABS CLOS DEVICE 3-0 CL 6 P-12

    MDR report key: 1832023 · Received September 8, 2010

    Report

    Report Number
    1219930-2010-00695
    Event Type
    Injury
    Date Received
    September 8, 2010
    Date of Event
    May 10, 2010
    Report Date
    August 12, 2010
    Manufacturer
    UNITED STATES SURGICAL
    Product Code
    GAM
    PMA / PMN Number
    K091087
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4)

    Description of Event or Problem · 1

    PROCEDURE: TAPP. ACCORDING TO THE REPORTER: FOUR TO FIVE WEEKS POSTOPERATIVE, A SUBILEUS RE-LAPAROSCOPY WAS NECESSARY BECAUSE THE PERITONEAL SEAM BECAME LOOSENED. AFTER LAPAROSCOPICAL EXCISION NEW COMPLICATIONS. THERE WAS NO EXTENSION IN OPERATING ROOM TIME, NO BLOOD LOSS, NO EXTENSION OF THE INCISION, AND NO LOSS OR DAMAGE OF TISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 V-LOC 180 ABS CLOS DEVICE 3-0 CL 6 P-12 ABSORBABLE BARBED DEVICE GAM UNITED STATES SURGICAL AOD1472U

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Other