BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EPISET NOVO QUI 2/0140CM HR37S/HS37SMDDP

    MDR report key: 15734738 · Received November 4, 2022

    Report

    Report Number
    3003639970-2022-00467
    Event Type
    Malfunction
    Date Received
    November 4, 2022
    Date of Event
    July 13, 2022
    Report Date
    February 17, 2023
    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
    RP
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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.UNDER PMA/510(K) NUMBER: K170661. IF ADDITIONAL INFORMATION BECOMES AVAILABLE A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    ANALYSIS AND RESULTS: THERE ARE NO PREVIOUS COMPLAINTS OF THE SAME 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 TO ANALYZE THIS CASE. WITHOUT ANY SAMPLE WE CANNOT CARRY OUT AN ANALYSIS IN ORDER TO TAKE A DECISION. REVIEWED THE BATCH MANUFACTURING RECORD, THIS PRODUCT HAD A NORMAL PROCESS AND THE RESULTS DURING THE PROCESS FULFIL USP/EP AND B. BRAUN SURGICAL REQUIREMENTS. WE HAVE ALSO REVIEWED THE COMPLAINT HISTORY RECORD, AND THERE ARE NO PREVIOUS COMPLAINTS IN ANY OF THE OTHER PRODUCTS MANUFACTURED WITH THE SAME THREAD RAW MATERIAL BATCHES AS THE USED IN THIS PRODUCT. AS STATED IN THE SIDE EFFECTS OF INSTRUCTIONS FOR USE OF THE PRODUCT: 'THE FOLLOWING SIDE EFFECTS MAY BE ASSOCIATED WITH THE USE OF THIS PRODUCT: TRANSITORY LOCAL IRRITATION, TRANSIENT INFLAMMATORY FOREIGN BODY REACTION, ENHANCED BACTERIAL INFECTIVITY, WOUND DEHISCENCE, GRANULATION.' 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. 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 · 0

    IT WAS REPORTED AN ISSUE WITH EPISET NOVOSYN QUICK SUTURE. THE CLIENT REPORTED THAT THEY HAVE NOTICED A PROLONGED ABSORBABILITY IN THESE SUTURES, BEING INTACT RANGING FROM 3 MONTHS TO 1 YEAR WHEN THIS SUTURE WOULD NORMALLY DISSOLVE WITHIN 1-2 WEEKS TO MAXIMUM 4 WEEKS. THIS RESULTED IN DISCOMFORT AND PAIN AND OTHER HAD UNDERGONE REPAIR. MORE INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2010572 EPISET NOVO QUI 2/0140CM HR37S/HS37SMDDP SYNTHETIC ABSORBABLE BRAIDED SUTURE GAM B. BRAUN SURGICAL, S.A. C3046913 120134

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other