BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MONOMAX VIOLET 1(4)150CM HRT40S LOOPM

    MDR report key: 7029038 · Received November 14, 2017

    Report

    Report Number
    3003639970-2017-00554
    Event Type
    Malfunction
    Date Received
    November 14, 2017
    Report Date
    December 15, 2017
    Manufacturer
    B.BRAUN SURGICAL SA
    Product Code
    NWJ
    PMA / PMN Number
    K100876
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    AESCULAP INC. (IMPORTER) IS SUBMITTING THIS REPORT ON BEHALF OF B. BRAUN SURGICAL S.A. (MANUFACTURER). EXEMPTION NUMBER: E2014012 MANUFACTURING SITE EVALUATION: EVALUATION ON-GOING H3 OTHER TEXT : DEVICE NOT RETURNED

    Description of Event or Problem · 0

    COUNTRY OF COMPLAINT: FRANCE. IT WAS REPORTED THAT TWO (2) PATIENTS WITH ABDOMINAL WALL INFECTIONS WITH MONOMAX. ALL MED WATCH SUBMISSIONS RELATED TO THIS REPORT ARE: 3003639970-2017-00551, 3003639970-2017-00554.

    Additional Manufacturer Narrative · 1

    SAMPLES RECEIVED: NONE. ANALYSIS AND RESULTS: BATCH NUMBER WAS NOT INFORMED. THE LIST OF DELIVERED BATCHES OF THE INVOLVED REFERENCE TO THE CUSTOMER IN THE PERIOD 10.2016 TO 09.2017 ARE: 117051 AND 117082. NO FURTHER INFORMATION RECEIVED REGARDING PATIENT CONDITIONS AND OUTCOME. WE HAVE CHECKED THE COMPLAINT HISTORY OF THE POSSIBLE BATCHES AND THERE ARE NO PREVIOUS COMPLAINTS OF ANY OF THEM. AS NO SAMPLES HAVE BEEN RECEIVED AND NO UNITS ARE AVAILABLE IN B. BRAUN SURGICAL, S.A. WE HAVE ONLY REVIEWED THE BATCH MANUFACTURING RECORDS AND THESE PRODUCTS HAD A NORMAL PROCESS AND THE RESULTS DURING THE PROCESS FULFILL USP/EP AND B. BRAUN SURGICAL REQUIREMENTS. THERE ARE NO INCIDENTS FOUND IN THE REVIEW. STERILIZATION METHOD USING ETHYLENE OXIDE HAS BEEN VALIDATED FOR THIS PRODUCT. AS INDICATED IN THE INSTRUCTIONS FOR USE OF THE PRODUCT: AS FOR ALL SUTURES AFTER IMPLANTATION A TRANSIENT INFLAMMATION, TEMPORARY IRRITATION AND INFECTION AT THE WOUND SIDE MAY OCCUR OCCASIONALLY. EXISTING INFECTIONS MAY OCCASIONALLY BE ENHANCED BY ANY FOREIGN BODY. AN OCCASIONAL WOUND DEHISCENCE AND GRANULATION MAY NOT BE EXCLUDED. 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. 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. 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    809680 MONOMAX VIOLET 1(4)150CM HRT40S LOOPM SUTURES NWJ B.BRAUN SURGICAL SA B0041185

    Patients

    Seq Age Sex Outcome Treatment
    1 Other