BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NOVOSYN VIOLET 2/0 (3) 6X45CM

    MDR report key: 4080787 · Received August 27, 2014

    Report

    Report Number
    2916714-2014-00686
    Event Type
    Malfunction
    Date Received
    August 27, 2014
    Date of Event
    July 21, 2014
    Report Date
    August 27, 2014
    Manufacturer
    B. BRAUN SURGICAL S.A..
    Product Code
    GAM
    PMA / PMN Number
    K122734
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    US REPORTING AGENT NOTIFIED ON: (B)(4) 2014. MFG SITE EVAL: SAMPLES RECEIVED: 32 UNOPENED POUCHES. THERE ARE NO PREVIOUS COMPLAINTS OF THIS CODE/BATCH. THERE ARE UNITS IN OEM STOCK. TESTED THE KNOT SECURITY CONTROL OF THE SAMPLES RECEIVED AND THE RESULTS ARE INTO THE CURRENT RANGE FOR THIS THREAD AND SIZE. TESTED THE KNOT PULL TENSILE STRENGTH OF THE SAMPLES RECEIVED AND THE RESULTS FULFILL THE REQUIREMENTS OF THE OEM. REVIEWED THE BATCH MFG RECORD, THIS PRODUCT HAD A NORMAL PROCESS AND THE RESULTS DURING THE PROCESS FULFILL 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

    COUNTY OF COMPLAINT: (B)(6). COMPLAINT STATES: KNOT SECURITY IS DECAYED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    518794 NOVOSYN VIOLET 2/0 (3) 6X45CM SYNTHETIC ABSORBABLE SUTURE GAM B. BRAUN SURGICAL S.A.. C0058646 114223

    Patients

    Seq Age Sex Outcome Treatment
    1 Other