BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NOVOSYN QUICK

    MDR report key: 8080330 · Received November 16, 2018

    Report

    Report Number
    3003639970-2018-00718
    Event Type
    Malfunction
    Date Received
    November 16, 2018
    Report Date
    December 19, 2018
    Manufacturer
    B. BRAUN SURGICAL SA
    Product Code
    GAM
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 0

    AESCULAP INC. (IMPORTER, REGISTRATION NO. 2916714) IS SUBMITTING THIS REPORT ON BEHALF OF B. BRAUN SURGICAL S.A. (MANUFACTURER, REGISTRATION NO. 3003639970). EXEMPTION NUMBER: E2014012. REPORTED DEVICE NOT MARKETED IN THE U.S., HOWEVER, SIMILAR DEVICES OR DEVICES THAT SHARE COMPONENTS, RAW MATERIALS, PROCESS METHODS OR OTHER TECHNOLOGICAL CHARACTERISTICS ARE REGISTERED WITHIN THE U.S. DATE OF EVENT: UNKNOWN. WHEN ADDITIONAL INFORMATION IS RECEIVED A FOLLOW UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    WE HAVE NOT RECEIVED INFORMATION REGARDING THE POSSIBLE NOVOSYN QUICK CODE/S-BATCH/ES INVOLVED IN THIS CASE. WITHOUT THIS INFORMATION A PROPER ANALYSIS CANNOT BE DONE AS THE REVIEW OF THE BATCH MANUFACTURING RECORDS CANNOT BE DONE EITHER. WITHOUT SAMPLES WE ARE NOT IN POSITION OF STUDYING IF THE AFFECTED PRODUCT DOES NOT FULFIL THE SPECIFICATIONS. IN CONSEQUENCE, A PROPER ANALYSIS CANNOT BE DONE AND THE CASE IS NOT CONFIRMED DUE TO LACK OF EVIDENCE. NEVERTHELESS, WE TAKE NOTE OF THIS INCIDENCE AND IF ANY SAMPLE OR INFORMATION REGARDING THE REFERENCE INVOLVED IS RECEIVED IN THE FUTURE, WE WILL RE-OPEN THE CASE AND ANALYZE IT. PLEASE NOTE THAT WHEN NO SAMPLES ARE RECEIVED OUR ANALYSIS IS VERY LIMITED. BASED ON THE CONCLUSION DERIVED FROM INVESTIGATION, IT IS NOT REQUIRED TO MAKE ACTIONS IN DISTRIBUTED PRODUCT. ACCORDING TO OUR INTERNAL PROCEDURES, THERE IS NO NEED TO ESTABLISH CORRECTIVE OR PREVENTIVE ACTIONS. NEVERTHELESS, THIS COMPLAINT IS RECORDED FOR TRENDING ANALYSIS TO ASSESS IF ACTIONS ARE NEEDED IN THE FUTURE.

    Description of Event or Problem · 0

    IT WAS REPORTED BY THE HEALTHCARE PROFESSIONAL "INFECTIONS OCCURRED ON 3 PATIENTS WITH NOVOSYN QUICK 3/0. THE WIRES WERE NOT RESORBED AND THERE WAS PRESENCE OF ABSCESSES." ADDITIONAL INFORMATION HAS BEEN REQUESTED HOWEVER, NOT YET RECEIVED. IF ADDITIONAL INFORMATION IS RECEIVED A FOLLOW UP REPORT WILL BE SUBMITTED. ALL MED WATCH SUBMISSIONS RELATED TO THIS PATIENT ARE: 3003639970-2018-00719; 3003639970-2018-00720.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    919018 NOVOSYN QUICK SUTURE GAM B. BRAUN SURGICAL SA B50101

    Patients

    Seq Age Sex Outcome Treatment
    1 Other