BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NOVOSYN VIOLET 0 (3.2) 70CM HR26S (M)

    MDR report key: 3880712 · Received May 28, 2014

    Report

    Report Number
    2916714-2014-00405
    Event Type
    Malfunction
    Date Received
    May 28, 2014
    Date of Event
    April 24, 2014
    Report Date
    May 28, 2014
    Manufacturer
    B. BRAUN SURGICAL S.A.
    Product Code
    GAW
    PMA / PMN Number
    K122734
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURING SITE EVALUATION: EVALUATION ON-GOING AT MANUFACTURING SITE. US REPORTING AGENT NOTIFIED ON (B)(4) 2014.

    Description of Event or Problem · 1

    COUNTRY OF COMPLAINT: (B)(6). INNER FOIL WAS WELDED WITH OUTER FOIL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    313550 NOVOSYN VIOLET 0 (3.2) 70CM HR26S (M) SYNTHETIC ABSORBABLE SUTURE GAW B. BRAUN SURGICAL S.A. C0068091 114064V004

    Patients

    Seq Age Sex Outcome Treatment
    1 Other