BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NOVOSYN VIOLET 1 (4) 90CM HR37S (M)

    MDR report key: 9802563 · Received March 6, 2020

    Report

    Report Number
    3003639970-2020-00128
    Event Type
    Injury
    Date Received
    March 6, 2020
    Date of Event
    January 13, 2020
    Report Date
    April 14, 2020
    Manufacturer
    B. BRAUN SURGICAL SA
    Product Code
    GAW
    PMA / PMN Number
    SEE H10
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL DATA: NEW INFORMATION RECEIVED CLARIFIED: A2 UPDATED, A4 UPDATED. SAMPLES RECEIVED: THERE ARE NO SAMPLES AVAILABLE FOR ANALYSIS. ANALYSIS AND RESULTS: THERE ARE NO PREVIOUS COMPLAINTS OF THIS CODE-BATCH. WE MANUFACTURED AND DISTRIBUTED IN THE MARKET (B)(4) UNITS OF THIS CODE-BATCH. THERE ARE NO UNITS IN OUR STOCK. WE HAVE NOT RECEIVED ANY SAMPLE FOR ANALYSIS. WITHOUT ANY SAMPLE WE CANNOT CARRY OUT AN ANALYSIS IN ORDER TO TAKE A DECISION. AS NO SAMPLES HAVE BEEN RECEIVED AND NO UNITS ARE AVAILABLE IN B. BRAUN SURGICAL'S WAREHOUSE, WE HAVE ONLY BEEN ABLE TO CONDUCT A REVIEW OF THE BATCH MANUFACTURING RECORD AND THE RESULTS DURING THE PROCESS FULFILL USP/EP AND B. BRAUN SURGICAL REQUIREMENTS. NEVERTHELESS, THERE ARE RISKS (SIDE EFFECTS) ASSOCIATED TO THE USE OF NOVOSYN SUTURE, WHICH ARE MENTIONED IN THE INSTRUCTIONS FOR USE OF THE PRODUCT: AN EXISTING INFECTION MAY BE NEGATIVELY INFLUENCED BY ANY ABSORBABLE SUTURE. THE DEGRADATION OF THE SUTURE MAY ALSO BE SLIGHTLY ACCELERATED DEPENDING ON THE PATIENT AND THE SEVERITY OF INFECTION. THE FOLLOWING SIDE EFFECTS MAY BE ASSOCIATED WITH THE USE OF THIS PRODUCT: PAIN, GRANULOMA, SEROMA, HEMATOMA, REJECTION, ENHANCED BACTERIAL INFECTIVITY, WOUND DEHISCENCE, ANASTOMOTIC LEAK AND HEMORRHAGE. 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 ANALYZE IT. PLEASE NOTE THAT WHEN NO SAMPLES ARE RECEIVED OUR ANALYSIS IS VERY LIMITED. 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.

    Additional Manufacturer Narrative · 1

    K133890. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS AN ISSUE WITH NOVOSYN VIOLET. SUTURE UNSTITCHING: A (B)(6) PATIENT, 37.2 WEEKS PREGNANT, WITH PREMATURE RUPTURE OF MEMBRANES, WAS ADMITTED BY TRANSPERITONEAL SEGMENTAL CAESAREAN SECTION AT 9 PM ON (B)(6) 2020, WITH A SATISFACTORY PROCEDURE AND SUBSEQUENT CLOSURE OF 3 CONTINUOUS CROSSED PLANES, USING NOVOSYN 1 FOR FASCIAL CLOSURE AND PREMILENE 2 FOR INTRADERMAL SUTURE. THE PROCEDURE WAS NOT COMPLICATED, AND AFTER 30 MINUTES SHE SHOWED INTENSE ABDOMINAL PAIN "LIKE A TIGHTENING BELT". ON (B)(6) 2020, AFTER 1 HOUR, THE PATIENT SHOWS SIGNS OF FLUID LEAKAGE DUE TO A SURGICAL WOUND, WITH PARTIAL DEHISCENCE, AND FIVE MINUTES LATER WITH COMPLETE DEHISCENCE AND EXPOSURE OF INTESTINAL LOOPS. IMMEDIATE TRANSFER IS GENERATED TO CLOSE THE POSTOPERATIVE DISRUPTION OF THE ABDOMINAL WALL IN WHICH A RUPTURE OF THE MIDDLE THIRD OF THE PROLENE IS DETECTED WITH SUTURE KNOTS ON BOTH INTEGRAL SIDES, PROCEEDING TO CLOSE THE FASCIA WITH NOVOSYN 1 AND FOR INTRADERMAL SUTURE WITH PREMILENE 2. THERE IS NO FURTHER PATIENT INFORMATION AVAILABLE, BUT HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    262441 NOVOSYN VIOLET 1 (4) 90CM HR37S (M) SYNTHETIC ABSORBABLE BRAIDED S GAW B. BRAUN SURGICAL SA C0068597 119392

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR Required Intervention