BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDO STITCH POLYSORB 0 48 U/D DLU SU

    MDR report key: 1971826 · Received January 5, 2011

    Report

    Report Number
    1219930-2010-00983
    Event Type
    Injury
    Date Received
    January 5, 2011
    Date of Event
    September 29, 2010
    Report Date
    November 28, 2010
    Manufacturer
    UNITED STATES SURGICAL
    Product Code
    KOG
    PMA / PMN Number
    K934738
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE: LAPAROSCOPIC TOTAL HYSTERECTOMY. ACCORDING TO THE REPORTER: THE NEEDLE BROKE IN HALF AND COULD NOT BE RECOVERED AS IT WAS LODGED AND LOST IN THE VAGINAL TISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDO STITCH POLYSORB 0 48 U/D DLU SU DISPOSABLE SUTURING DEVICE KOG UNITED STATES SURGICAL UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other