BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDO STITCH SURGIDAC 2/0 7 GRN DLU TU

    MDR report key: 1901080 · Received November 10, 2010

    Report

    Report Number
    1219930-2010-00855
    Event Type
    Malfunction
    Date Received
    November 10, 2010
    Date of Event
    October 18, 2010
    Report Date
    October 19, 2010
    Manufacturer
    UNITED STATES SURGICAL
    Product Code
    KOG
    PMA / PMN Number
    K934738
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SD REFERENCE #: (B)(4) . DATE OF INITIAL REPORT SENT: (B)(4) 2010.

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER: THE SUTURE BROKE BUT THE PIECE WAS RECOVERED. THERE WAS NO BLEEDING REPORTED IN EXCESS OF 250 CC. THE CASE WAS NOT EXTENDED BY MORE THAN 30 MINUTES. THERE WAS NO UNANTICIPATED TISSUE LOSS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDO STITCH SURGIDAC 2/0 7 GRN DLU TU DISPOSABLE SUTURING DEVICE KOG UNITED STATES SURGICAL N9M0457

    Patients

    Seq Age Sex Outcome Treatment
    1