BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BONE WAX 24X2.5G

    MDR report key: 7522958 · Received May 17, 2018

    Report

    Report Number
    3003639970-2018-00278
    Event Type
    Malfunction
    Date Received
    May 17, 2018
    Report Date
    May 17, 2018
    Manufacturer
    B.BRAUN SURGICAL SA
    Product Code
    MTJ
    PMA / PMN Number
    K000021
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    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: SAMPLES RECEIVED: NONE, PICTURES RECEIVED SHOWING THE DEFECT. ANALYSIS AND RESULTS: THERE ARE NO PREVIOUS COMPLAINTS OF THIS CODE BATCH OF WHICH (B)(4) UNITS WERE MANUFACTURED AND DISTRIBUTED IN THE MARKET. THERE ARE NO UNITS IN STOCK IN THE WAREHOUSE. NO SAMPLES HAVE BEEN RECEIVED BUT PICTURES ATTACHED SHOWS A SECONDARY PACKAGING WITH A PRIMARY PACKAGING WITHOUT PRODUCT. BETWEEN THE DIFFERENT ORDERS EMPTY PACKAGES ARE DRIVEN TO EXCLUDE A MIXING WITH THE RESPECTIVE ORDERS. THESE EMPTY UNITS SHOULD BE DISCARDED BY THE PERSONNEL IN PRODUCTION. REVIEWED THE BATCH MANUFACTURING RECORDS THIS PRODUCT HAD A NORMAL PROCESS AND RESULTS DURING PROCESS FULFILLED THE OEM SPECIFICATIONS. TAKING INTO ACCOUNT THAT NO OTHER COMPLAINTS HAVE BEEN RECEIVED REGARDING THIS ISSUE, IT IS CONSIDERED THAT THIS IS AN ISOLATED AND ACCIDENTAL ISSUE. FINAL CONCLUSION: TAKING INTO ACCOUNT THAT THE RESULTS OF SAMPLES RECEIVED DO NOT FULFILL THE OEM SPECIFICATIONS, IT IS CONCLUDED THAT THE COMPLAINT IS JUSTIFIED. 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. THIS REPORT IS BEING SUBMITTED LATE DUE TO MIS-INTERPRETATION OF 2 YEAR PRESUMPTION ACKNOWLEDGEMENT AND AGREEMENT BY FDA. ONCE ISSUE WAS IDENTIFIED, RETROSPECTIVE REVIEW OF COMPLAINTS WAS COMPLETED FROM TIME OF 2 YEAR PRESUMPTION IMPLEMENTATION TO PRESENT. ALL REPORTS IDENTIFIED ARE BEING REPORTED.

    Description of Event or Problem · 0

    COUNTRY OF COMPLAINT: CHINA. IT IS REPORTED THAT THERE'S NO PRODUCT INSIDE THE PACKAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    366480 BONE WAX 24X2.5G BIOSURGICALS MTJ B.BRAUN SURGICAL SA 1029754 216271

    Patients

    Seq Age Sex Outcome Treatment
    1 Other