BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NOVOSYN VIOLET 1(4)150CM HRC48 LOOP(M

    MDR report key: 11883150 · Received May 26, 2021

    Report

    Report Number
    3003639970-2021-00181
    Event Type
    Injury
    Date Received
    May 26, 2021
    Date of Event
    March 16, 2021
    Report Date
    June 28, 2021
    Manufacturer
    B. BRAUN SURGICAL, S.A.
    Product Code
    GAM
    PMA / PMN Number
    K122734
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    ANALYSIS AND RESULTS: THE CUSTOMER HAS NOT INFORMED OF THE POSSIBLE BATCHES. LIST OF BATCHES SUPPLIED TO THE CUSTOMER IN THE LAST 6 MONTHS: 720364, 120292, 720272, 120133 AND 120115. THERE ARE NO PREVIOUS COMPLAINTS OF ANY OF THE BATCHES. WE MANUFACTURED 552 UNITS OF THE BATCH 720364, 1.272 UNITS OF BATCH 120292, 1.008 OF BATCH 720272, 1.080 UNITS OF BATCH 120133 AND 768 UNITS OF THE BATCH 120115. THERE ARE NO UNITS IN STOCK OF ANY OF THE POSSIBLE BATCHES. WITHOUT CLOSED SAMPLES AND/OR DEFECTIVE SAMPLES A PROPER ANALYSIS CANNOT BE PERFORMED. REVIEWED THE BATCH MANUFACTURING RECORDS, THESE PRODUCTS HAD A NORMAL PROCESS AND THE RESULTS DURING THE PROCESS FULFILLED USP/EP AND BBS REQUIREMENT. PLEASE NOTE THAT NOVOSYN® IS METABOLIZED TO GLYCOLIC ACID AND LACTICACID BY HYDROLYSIS WITHOUT CAUSING ANY ENDURING CHANGE IN THE REGION OF THE WOUND. 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. IN CONSEQUENCE, WHEN THE SURGEON RE-OPENED THE WOUND AT DAY 28, ONLY 25% OF THE ORIGINAL TENSILE STRENGTH REMAINED IN THE THREAD. NOVOSYN® SUTURE MATERIALS ARE CONTRA-INDICATED FOR APPLICATIONS WHERE PROLONGED SUPPORT OF THE WOUND CLOSURE BY THE SUTURE MATERIAL IS REQUIRED. MOREOVER, IN THE PRECAUTIONS POINT IN THE INSTRUCTIONS FOR USE OF THE PRODUCT IT IS STATE THAT THE USAGE OF NOVOSYN® MAY NOT BE ADVISED INCASE OF ELDERLY OR MALNOURISHED OR DEBILITATED PATIENTS, OR IN PATIENTS SUFFERING FROM DISEASES OR CONDITIONS WHICH DELAY THE WOUND HEALING PROCESS. FOR ABDOMINAL WALL CLOSURE MONOMAX IS MORE RECOMMEND. MONOMAX IS ASTERILE EXTRA LONG-TERM ABSORBABLE MONOFILAMENT. MONOMAX ABSORBABLESUTURES ARE INDICATED FOR USE IN GENERAL SOFT TISSUE APPROXIMATION WHEN EXTENDED WOUND SUPPORT IS NEEDED (MORE THAN 3 MONTHS) IN ABDOMINAL FASCIAL CLOSURE. FINAL CONCLUSION: 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 IS RECEIVED IN THE FUTURE, WE WILL RE-OPEN THE CASE AND ANALYSE IT. PLEASE NOTE THAT WHEN NO SAMPLES ARE RECEIVED OUR ANALYSIS IS VERY LIMITED. WE REGRET ANY INCONVENIENCE THIS ISSUE MAY HAVE CAUSED AND THANK YOU FOR YOUR COLLABORATION. 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

    IF ADDITIONAL INFORMATION BECOMES AVAILABLE A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED AN ISSUE WITH NOVOSYN SUTURES. ON (B)(6) 2021, THE PATIENT WAS TAKEN TO THE OPERATING ROOM FOR AN EVISCERATION CURE AT D28 OF A LAPAROTOMY (INTRAPERITONEAL HYPERTHERMIC CHEMOTHERAPY (HIPEC) (ON (B)(6) 2021). DURING THE HIPEC, THE ABDOMINAL WALL WAS SUTURED WITH NOVOSYN TO REINFORCE THE SUTURE AND AVOID ANY RISK OF EVISCERATION. DURING THE REVISION, THE APONEUROSIS SEEMS TO HAVE BEEN CUT CLEANLY ("AS IF A SCISSORS HAD SHEARED OFF ALL THE THREADS ALONG THE SURGICAL EDGES") NEED TO REOPEN THE PATIENT TO CLOSE THE ABDOMINAL WALL. MORE INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    779133 NOVOSYN VIOLET 1(4)150CM HRC48 LOOP(M SYNTHETIC ABSORBABLE BRAIDED SUTURE GAM B. BRAUN SURGICAL, S.A. B0068987

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention