BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BONE WAX 24X2.5G

    MDR report key: 7545733 · Received May 25, 2018

    Report

    Report Number
    3003639970-2018-00341
    Event Type
    Malfunction
    Date Received
    May 25, 2018
    Report Date
    August 29, 2018
    Manufacturer
    B.BRAUN SURGICAL SA
    Product Code
    MTJ
    PMA / PMN Number
    K000021
    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.

    Description of Event or Problem · 0

    COUNTRY OF COMPLAINT: FRANCE. BAD QUALITY OF THE WAX, NO ADHERE TO THE BONE, BLOOD LOSS FOR PATIENTS, LOSS OF TIME FOR THE SURGEON AND BAD VISIBILITY DURING SURGERY.

    Additional Manufacturer Narrative · 1

    SAMPLES RECEIVED: 2 UNOPENED POUCHES. ANALYSIS AND RESULTS: THERE ARE NO PREVIOUS COMPLAINTS OF THIS CODE BATCH OF WHICH WE MANUFACTURED AND DISTRIBUTED (B)(4) UNITS IN THE MARKET. THERE ARE NO UNITS IN STOCK IN B. BRAUN SURGICAL'S WAREHOUSE. WE HAVE RECEIVED 2 SAMPLES. THE SAMPLES RECEIVED FULFILLED THE VISUAL SPECIFICATIONS OF THE PRODUCT. THE SAMPLES RECEIVED WERE ALSO TESTED FOR HANDLING USE. THIS MEANS THAT THE APPLICATION WAS SIMULATED AND NO ABNORMALITIES WERE FOUND. 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. PREFABRICATION DOCUMENTATION WAS ALSO REVIEWED AND NO DEVIATIONS WERE FOUND, INDIVIDUAL RAW MATERIALS (BEESWAX AND VASELINE) WERE CHECKED AND THE PRODUCT FULFILL THE SPECIFICATIONS OF THE EUROPEAN PHARMACOPOEIA. FINAL CONCLUSION: ALTHOUGH THE RESULTS OF THE SAMPLES RECEIVED FULFIL THE SPECIFICATIONS OF EUROPEAN PHARMACOPOEIA/B. BRAUN SURGICAL SPECIFICATIONS, WE TAKE NOTE OF THIS INCIDENCE IN ORDER TO ASSESS IF NEW OR ADDITIONAL ACTIONS ARE NEEDED. THE CASE IS CONSIDERED NOT CONFIRMED BY EVIDENCE OF THE SAMPLES RECEIVED. 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
    388592 BONE WAX 24X2.5G BONE WAX MTJ B.BRAUN SURGICAL SA 1029754

    Patients

    Seq Age Sex Outcome Treatment
    1 Other