BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PREMILENE 2/0 (3) 75CM HR30 (M)

    MDR report key: 3880704 · Received May 28, 2014

    Report

    Report Number
    2916714-2014-00394
    Event Type
    Malfunction
    Date Received
    May 28, 2014
    Date of Event
    April 1, 2014
    Report Date
    May 28, 2014
    Manufacturer
    B. BRAUN SURGICAL S.A.
    Product Code
    GAW
    PMA / PMN Number
    K980703
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION ON-GOING AT MANUFACTURING SITE.

    Description of Event or Problem · 1

    COUNTRY OF COMPLAINT: (B)(6). THREAD BROKE WHILE KNOTTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    313864 PREMILENE 2/0 (3) 75CM HR30 (M) CARDIAC SUTURE GAW B. BRAUN SURGICAL S.A. C2090047

    Patients

    Seq Age Sex Outcome Treatment
    1 Other