BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NOVOSYN

    MDR report key: 10094744 · Received May 28, 2020

    Report

    Report Number
    3003639970-2020-00212
    Event Type
    Injury
    Date Received
    May 28, 2020
    Report Date
    June 9, 2020
    Manufacturer
    B. BRAUN SURGICAL, S.A.
    Product Code
    GAM
    PMA / PMN Number
    SEE H10
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    ANALYSIS AND RESULTS: WE HAVE NOT RECEIVED ANY ADDITIONAL DATA OR INFORMATION ABOUT THE POSSIBLE NOVOSYN 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. AS INDICATED IN 'MODE OF ACTION' PARAGRAPH OF THE INSTRUCTIONS FOR USE OF THE PRODUCT, ABOUT 75% OF THE ORIGINAL TENSILE STRENGTH REMAINS AFTER 14 DAYS OF IMPLANTATION, ABOUT 40-50% AFTER 21 DAYS AND ABOUT 25% AFTER 28 DAYS. THE COMPLETE MASS ABSORPTION OF NOVOSYN® TAKES PLACE AT 56-70 DAYS, WHEN THE TISSUE IS NORMALLY PERFUSED. NEVERTHELESS, AS STATED IN THE 'MODE OF APPLICATION' PARAGRAPH IN THE INSTRUCTIONS FOR USE OF THE NOVOSYN PRODUCT, SUTURES SHOULD BE SELECTED DEPENDING ON THE TISSUE TO BE SUTURED, THE SPECIFIC DURATION OF WOUND SUPPORT NEEDED, THE SIZE OF THE WOUND, THE PATIENT'S CONDITION AND THE SPECIFIC SUTURING TECHNIQUE. AS IT IS ALSO MENTIONED IN THE 'PRECAUTIONS' PARAGRAPH OF THE INSTRUCTIONS FOR USE, CONSIDERATION SHOULD BE TAKEN IN THE USE OF ABSORBABLE SUTURES IN TISSUES WITH POOR BLOOD SUPPLY AS SUTURE EXTRUSION AND DELAYED ABSORPTION MAY OCCUR. SUBCUTICULAR SUTURES SHOULD BE PLACED AS DEEPLY AS POSSIBLE TO MINIMIZE THE ERYTHEMA AND INDURATION NORMALLY ASSOCIATED WITH THE ABSORPTION PROCESS. USAGE OF NOVOSYN® MAY NOT BE ADVISED IN CASE OF ELDERLY OR MALNOURISHED OR DEBILITATED PATIENTS, OR IN PATIENTS SUFFERING FROM DISEASES OR CONDITIONS WHICH DELAY THE WOUND HEALING PROCESS. FINAL CONCLUSION: WITHOUT SAMPLES OR MORE INFORMATION, WE ARE NOT IN POSITION OF STUDYING IF THE INVOLVED 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 ABOUT THIS CASE IS RECEIVED IN THE FUTURE, WE WILL RE-OPEN THE CASE AND ANALYZE IT. ACTIONS ON PRODUCT DISTRIBUTED OF THIS REFERENCE/BATCH: BASED ON THE CONCLUSION DERIVED FROM INVESTIGATION, IT IS NOT REQUIRED TO MAKE ACTIONS IN DISTRIBUTED PRODUCT. CORRECTIVE/PREVENTIVE ACTIONS: 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.

    Additional Manufacturer Narrative · 1

    THE INVOLVED PRODUCT IS NOT KNOWN (REFERENCE NOR BATCH NUMBER). AS THE PRODUCT INVOLVED IS NOT KNOWN, WE CAN NOT DETERMINE IF REPORTED DEVICE IS 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. K122734. IF ADDITIONAL INFORMATION BECOMES AVAILABLE A FOLLOW UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED AN ISSUE WITH NOVOZYM SUTURE. A CUSTOMER REPORTED THAT A NOVOZYM THREAD OF USP 1 SIZE WAS NOT ABSORBED AFTER 1.5 YEARS OF SURGERY. THE SURGERY WAS PERFORMED IN APPROXIMATELY (B)(6) 2016. AFTER 1.5 YEARS, THE HOSPITAL FOUND REMNANTS OF THE THREAD AND IT WAS NECESSARY TO "EXPLANT" REMAINING SUTURE MATERIAL. AT THIS TIME, NO MORE INFORMATION HAS BEEN RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    561891 NOVOSYN SYNTHETIC ABSORBABLE BRAIDED GAM B. BRAUN SURGICAL, S.A. SEE H10 SEE H10

    Patients

    Seq Age Sex Outcome Treatment
    1 Other