BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NOVOSYN UNDYED 3/0 (2) 70CM DS24 (M)

    MDR report key: 3812590 · Received April 17, 2014

    Report

    Report Number
    2916714-2014-00262
    Event Type
    Malfunction
    Date Received
    April 17, 2014
    Report Date
    April 17, 2014
    Manufacturer
    B. BRAUN SURGICAL S.A.
    Product Code
    GAM
    PMA / PMN Number
    K122734
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NO
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION ON-GOING.

    Description of Event or Problem · 1

    COUNTRY OF COMPLAINT: (B)(6). NEEDLE AND THREAD DETACHMENT. HAS HAPPENED IN DIFFERENT GYN PROCEDURES. SOME SUTURES ARE FOUND TO BE NOT CONNECTED TO THE NEEDLE WHILE IN THE ENVELOPE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    236256 NOVOSYN UNDYED 3/0 (2) 70CM DS24 (M) GAM B. BRAUN SURGICAL S.A. C0069235 113404

    Patients

    Seq Age Sex Outcome Treatment
    1