BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NOVOSYN 6/0

    MDR report key: 12202383 · Received July 21, 2021

    Report

    Report Number
    3003639970-2021-00362
    Event Type
    Injury
    Date Received
    July 21, 2021
    Date of Event
    April 6, 2021
    Report Date
    July 21, 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
    DA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CODE-BATCH IS NOT KNOWN. THE POSSIBLE PRODUCT REFERENCES INVOLVED ARE: (B)(4) (NOVOSYN VIOLET 6/0(0.7)20CM 2XVLM8 (M)) AND (B)(4) (NOVOSYN UNDYED 6/0(0.7)45CM 2XHLM8 (M). THE POSSIBLE LOT NUMBERS ARE: FOR THE REFERENCE (B)(4): 120452, 120522, 120481,120096. FOR THE REFERENCE (B)(4): 119382, 119465, 120506, 121091, 121146, 121104. ANALYSIS AND RESULTS: THERE ARE NO PREVIOUS COMPLAINTS OF ANY OF THE POSSIBLE CODES-BATCHES INVOLVED IN THIS CASE. POSSIBLE REFERENCE (B)(4): WE MANUFACTURED AND DISTRIBUTED IN THE MARKET (B)(4) UNITS OF THE BATCH 120452, (B)(4) UNITS OF THE BATCH 120522, (B)(4) UNITS OF THE BATCH 120481, (B)(4) UNITS OF THE BATCH 120096. POSSIBLE REFERENCE (B)(4): WE MANUFACTURED AND DISTRIBUTED IN THE MARKET (B)(4) UNITS OF THE BATCH 119382, (B)(4) UNITS OF THE BATCH 119465, (B)(4) UNITS OF THE BATCH 120506, (B)(4) UNITS OF THE BATCH 121091, (B)(4) UNITS OF THE BATCH 121146 AND (B)(4) UNITS OF THE BATCH 121104. THERE ARE NO UNITS IN STOCK OF THE POSSIBLE CODES-BATCHES REPORTED. WE HAVE NOT RECEIVED ANY SAMPLE TO ANALYZE THIS CASE. WITHOUT ANY SAMPLE, WE CANNOT CARRY OUT AN ANALYSIS IN ORDER TO TAKE A DECISION. REVIEWED THE BATCH MANUFACTURING RECORDS, THESE PRODUCTS HAD A NORMAL PROCESS AND THE RESULTS DURING THE PROCESS FULFIL USP/EP AND B. BRAUN SURGICAL REQUIREMENTS. AS MENTIONED IN THE INSTRUCTIONS FOR USE (IFU) OF THE PRODUCT, SUTURE MATERIALS ARE USED PRIMARILY FOR ADAPTATION OF THE WOUND EDGES TO RENDER POSSIBLE AN UNDISTURBED WOUND HEALING. DURING THE USE OF NOVOSYN¿ SUTURES A MILD INFLAMMATORY REACTION MAY OCCUR, WHICH IS TYPICAL FOR AN ENDOGENOUS REACTION TO A FOREIGN BODY. AS TIME PASSES THE SUTURE MATERIAL IS ENCAPSULATED BY FIBROUS CONNECTIVE TISSUE. FINAL CONCLUSION: WITHOUT SAMPLES WE ARE NOT IN POSITION OF STUDYING IF THE POSSIBLE AFFECTED PRODUCTS DO NOT FULFIL THE SPECIFICATIONS. IN CONSEQUENCE, A PROPER ANALYSIS CANNOT BE DONE, AND THE CASE IS NOT CONFIRMED DUE TO LACK OF EVIDENCE. ANYWAY, WE TAKE NOTE OF THIS INCIDENCE AND IF SAMPLES OR MORE INFORMATION ARE RECEIVED IN THE FUTURE, WE WILL RE-OPEN THE CASE AND ANALYSE IT. NEVERTHELESS, ACCORDING TO THE BATCH MANUFACTURING RECORDS REVIEW, THE POSSIBLE PRODUCTS COMPLY WITH B. BRAUN SURGICAL SPECIFICATIONS AND EP REQUIREMENTS. THEREFORE, WE DO NOT SEE ANY MANUFACTURING FAULT OR MATERIAL DEFECT THAT COULD HAVE CAUSED THE INCIDENCE. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED AN ISSUE WITH NOVOSYN SUTURE. THE CUSTOMER REPORTED THAT A WOMAN WHO WAS OPERATED OF STRABISMUS SURGERY, SWELLING OR INFLAMMATION WAS SEEN OVER THE AREA WHERE THE NOVOSYN SUTURES WERE IMPLANTED (SCLERA) 4-5 WEEKS AFTER SURGERY. PRE AND POSTOPERATIVE CONDITIONS WERE UNCOMPLICATED. IT WAS INTERPRETED AS A SUTURE REACTION AND PATIENT TREATED WITH STEROIDS AND ANTIBIOTICS. 3 MONTHS POSTOPERATIVELY, THERE WAS A NORMAL BEHAVIOUR. INOCULATION TO R+D WAS NEGATIVE FOR BACTERIA AND FUNGI. THE CONSEQUENCES REPORTED WERE: GIVEN LOCAL DISCOMFORT, AS WELL AS MODERATE SWELLING / REACTION OVER THE AREA WHERE THE SCLERAL SUTURES HAVE BEEN INSERTED. IT IS NOT KNOWN WHICH NOVOSYN USP 6/0 THREAD HAS BEEN USED IN THE OPERATION. NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1103403 NOVOSYN 6/0 SYNTHETIC ABSORBABLE BRAIDED SUTURES GAM B. BRAUN SURGICAL, S.A. SEE H10 SEE H10

    Patients

    Seq Age Sex Outcome Treatment
    1 Other