BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDO STITCH SURGIDAC 2/0 48 GRN DLU SU

    MDR report key: 1925910 · Received November 23, 2010

    Report

    Report Number
    1219930-2010-00890
    Event Type
    Malfunction
    Date Received
    November 23, 2010
    Date of Event
    October 20, 2010
    Report Date
    October 28, 2010
    Manufacturer
    UNITED STATES SURGICAL
    Product Code
    KOG
    PMA / PMN Number
    K934738
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER: THE NEEDLE DETACHED FROM THE SUTURE STRAND. ADDITIONAL INFO HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDO STITCH SURGIDAC 2/0 48 GRN DLU SU DISPOSABLE SUTURING DEVICE KOG UNITED STATES SURGICAL N9K0448

    Patients

    Seq Age Sex Outcome Treatment
    1