BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NOVOSYN VIOLET 1 (4) 90CM HR 37S (M)

    MDR report key: 3982610 · Received June 16, 2014

    Report

    Report Number
    2916714-2014-00462
    Event Type
    Malfunction
    Date Received
    June 16, 2014
    Date of Event
    May 6, 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
    CO
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    US REPORTING AGENT NOTIFIED ON: (B)(4) 2014. MANUFACTURING SITE EVALUATION: SAMPLES RECEIVED: 4 UNOPENED AND 2 OPEN POUCHES. THERE ARE NO PREVIOUS COMPLAINTS OF THIS CODE/BATCH. THERE ARE NO UNITS IN OEM STOCK. ALL CLOSED PACKS RECEIVED ARE TIGHT. WE HAVE RECEIVED 4 CLOSED AND 2 OPEN PACKS WITH THE THREAD USED AND BROKEN. TESTED THE KNOT PULL TENSILE STRENGTH OF CLOSED SAMPLES RECEIVED AND THE RESULTS FULFIL THE REQUIREMENTS OF THE OEM. REVIEWED THE BATCH MANUFACTURING RECORD, THIS PRODUCT HAD A NORMAL PROCESS AND THE RESULTS DURING THE PROCESS FULFIL OEM REQUIREMENTS. FINAL CONCLUSION: THE COMPLAINT IS NOT CORRESPONDING (NOT JUSTIFIED). ACTIONS ON PRODUCT: NOT APPLICABLE. CORRECTIVE/PREVENTIVE ACTIONS: NOT APPLICABLE.

    Description of Event or Problem · 1

    COUNTRY OF COMPLAINT: (B)(6). SUTURE FRAYS DURING CLOSING OF ABDOMINAL WALL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    353524 NOVOSYN VIOLET 1 (4) 90CM HR 37S (M) SUTURE GAM B. BRAUN SURGICAL S. A. C0068597 113374

    Patients

    Seq Age Sex Outcome Treatment
    1 Other