BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MONOSYN VIOLET 2 (5) 90CM HS48 (M) DDP

    MDR report key: 8090186 · Received November 20, 2018

    Report

    Report Number
    3003639970-2018-00723
    Event Type
    Injury
    Date Received
    November 20, 2018
    Date of Event
    October 23, 2018
    Report Date
    January 7, 2019
    Manufacturer
    B. BRAUN SURGICAL SA
    Product Code
    GAM
    PMA / PMN Number
    SEE H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    AESCULAP INC. (IMPORTER, REGISTRATION NO. 2916714) IS SUBMITTING THIS REPORT ON BEHALF OF B. BRAUN SURGICAL S.A. (MANUFACTURER, REGISTRATION NO. 3003639970). EXEMPTION NUMBER: E2014012. 510K: K011375. REPORTED DEVICE NOT MARKETED IN THE U.S., HOWEVER, SIMILAR DEVICES OR DEVICES THAT SHARE COMPONENTS, (B)(4) MATERIALS, PROCESS METHODS OR OTHER TECHNOLOGICAL CHARACTERISTICS ARE REGISTERED WITHIN THE U.S. (B)(4). MANUFACTURING SITE EVALUATION: INVESTIGATION ON-GOING. ADDITIONAL INFORMATION / INVESTIGATION RESULTS WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 0

    WE HAVE RECEIVED ONE CLOSED SAMPLE TO ANALYZE THIS COMPLAINT. TIGHTNESS TEST TO THE CLOSED SAMPLE RECEIVED HAS BEEN PERFORMED AND THE UNIT IS TIGHT. MONOSYN® BIOCOMPATIBILITY HAS BEEN TESTED IN SEVERAL EXPERIMENTS. IN SENSITIZATION AND IRRITATION TESTS THE HARMLESSNESS OF MONOSYN WAS PROVED. NEVERTHELESS, THERE ARE RISKS (SIDE EFFECTS) ASSOCIATED TO THE USE OF MONOSYN® SUTURE, WHICH ARE TYPICAL FOR ANY (ABSORBABLE) SUTURE AND WHICH ARE MENTIONED IN THE INSTRUCTIONS FOR USE OF THE PRODUCT: "AS FOR ALL SUTURES AFTER IMPLANTATION A TRANSIENT INFLAMMATION, TEMPORARY IRRITATION AND INFECTION AT THE WOUND SITE MAY OCCUR OCCASIONALLY. EXISTING INFECTIONS MAY OCCASIONALLY BE ENHANCED BY ANY FOREIGN BODY. AN OCCASIONAL WOUND DEHISCENCE AND GRANULATION MAY NOT BE EXCLUDED". REVIEWED THE BATCH MANUFACTURING RECORD, THIS PRODUCT HAD A NORMAL PROCESS AND THE RESULTS DURING THE PROCESS FULFILL USP/EP AND B.BRAUN SURGICAL REQUIREMENTS. STERILIZATION PROCESS WAS ALSO NORMAL AND THE RESULTS OF THE STERILIZATION CONTROL ARE CORRECT. ALTHOUGH THE RESULT OF THE SAMPLE RECEIVED FULFILS THE SPECIFICATIONS OF EUROPEAN PHARMACOPOEIA/ B. BRAUN SURGICAL SPECIFICATIONS. BASED ON THE CONCLUSION DERIVED FROM INVESTIGATION, IT IS NOT REQUIRED TO MAKE ACTIONS IN DISTRIBUTED PRODUCT. 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 THAT THERE WAS A POSTOPERATIVE INFECTION WHICH OCCURRED AFTER 5-6 DAYS. THE ISSUE OCCURRED AFTER A VETERINARY PROCEDURE AND PUS WAS NOTED AT THE ABDOMINAL WALL. ADDITIONAL INFORMATION WAS REQUESTED BUT NOT YET PROVIDED. ASSOCIATED MEDWATCH: 3003639970-2018-00724.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    931400 MONOSYN VIOLET 2 (5) 90CM HS48 (M) DDP SYNTHETIC ABSORBABLE MONOFILAR GAM B. BRAUN SURGICAL SA B0022279 118176

    Patients

    Seq Age Sex Outcome Treatment
    1