BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDO STICH SHORT INSTRUMENT

    MDR report key: 1040226 · Received May 8, 2008

    Report

    Report Number
    1219930-2008-00356
    Event Type
    Injury
    Date Received
    May 8, 2008
    Date of Event
    April 3, 2008
    Report Date
    April 9, 2008
    Manufacturer
    NORTH HAVEN - USS
    Product Code
    MFJ
    PMA / PMN Number
    K934738
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INITIAL REPORT SENT: 05/08/2008.

    Description of Event or Problem · 1

    PROCEDURE TYPE: UNK. ACCORDING TO THE RPTR: THE NEEDLE BROKE OFF IN THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDO STICH SHORT INSTRUMENT DISPOSABLE SUTURING DEVICE MFJ NORTH HAVEN - USS N7H35

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other