BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NOVOSYN VIOLET 3/0 (2) 70CM HR26 (M)

    MDR report key: 4213207 · Received September 26, 2014

    Report

    Report Number
    2916714-2014-00728
    Event Type
    Malfunction
    Date Received
    September 26, 2014
    Date of Event
    June 16, 2014
    Report Date
    September 26, 2014
    Manufacturer
    B. BRAUN SURGICAL S.A.
    Product Code
    GAM
    PMA / PMN Number
    K122734
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    US REPORTING AGENT NOTIFIED ON (B)(4) 2014. SAMPLES RECEIVED: NONE. THERE ARE NO PREVIOUS COMPLAINTS OF THIS CODE/BATCH. THERE ARE NO UNITS IN OEM STOCK. WITHOUT ANY CLOSED SAMPLED AND/OR DEFECTIVE SAMPLE WE CANNOT CARRY OUT A PROPER ANALYSIS. REVIEWED THE BATCH MANUFACTURING 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

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    603053 NOVOSYN VIOLET 3/0 (2) 70CM HR26 (M) NYLON SUTURE GAM B. BRAUN SURGICAL S.A. C0068041 114132

    Patients

    Seq Age Sex Outcome Treatment
    1 Other