BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NOVOSYN VIOLET 2 (5) 90CM HR40S (M)

    MDR report key: 3982652 · Received June 16, 2014

    Report

    Report Number
    2916714-2014-00466
    Event Type
    Malfunction
    Date Received
    June 16, 2014
    Report Date
    June 16, 2014
    Manufacturer
    B. BRAUN SURGICAL S.A.
    Product Code
    GAM
    PMA / PMN Number
    K122734
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    US REPORTING AGENT NOTIFIED ON (B)(4) 2014. EVAL: EVAL IN PROGRESS.

    Description of Event or Problem · 1

    COUNTRY OF COMPLAINT: (B)(6). FOREIGN BODY REACTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    353544 NOVOSYN VIOLET 2 (5) 90CM HR40S (M) SUTURE GAM B. BRAUN SURGICAL S.A. C0068558 113511

    Patients

    Seq Age Sex Outcome Treatment
    1 Other