BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BONE WAX 24X2.5G

    MDR report key: 3829717 · Received May 7, 2014

    Report

    Report Number
    3005673311-2014-00048
    Event Type
    Malfunction
    Date Received
    May 7, 2014
    Date of Event
    April 7, 2014
    Report Date
    May 7, 2014
    Manufacturer
    B. BRAUN SURGICAL S.A.
    Product Code
    MTJ
    PMA / PMN Number
    K000021
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURING SITE EVALUATION: SAMPLES RECEIVED: NONE. THERE ARE NO PREVIOUS COMPLAINTS RECEIVED FOR THIS CODE BATCH. THERE ARE FOUR COUNTRY-SPECIFIC LABEL LAYOUTS (B)(4) FOR THIS ARTICLE NUMBER. THESE LAYOUTS ARE ASSIGNED TO THE STORAGE LOCATIONS IN SAP DATABASE. THE COMPLAINT PRODUCT HAS THE LAYOUT (B)(4) AND THE LAYOUT THAT INCLUDES PORTUGUESE IS (B)(4). ACCORDING TO THE DHR THE BATCH NUMBER COMPLAINED IS CORRECTLY LABELED. THE ARTICLE NUMBER (B)(4) AND THE BATCH NUMBER (B)(4) WAS LABELED WITH THE LAYOUT (B)(4). THE SHIPPING MISTAKE TOOK PLACE WHEN THE SUBSIDIARY IN (B)(6) REMOVED THE "MATERIAL DETERMINATION" IN SAP AND WHEN THEY INTRODUCED THE ORDER AND SYSTEM CHOOSE THE INCORRECT LAYOUT. FINAL CONCLUSION: THE COMPLAINT IS CORRESPONDING (JUSTIFIED). CORRECTIVE/PREVENTIVE ACTIONS: THIS ERROR HAS BEEN CORRECTED.

    Description of Event or Problem · 1

    COUNTRY OF COMPLAINT: (B)(6). WE RECEIVED AN INFO FROM A CUSTOMER CONCERNING THE LABELING OF BONE WAX, REF (B)(4) THAT IS NOT IN (B)(4). THE BATCH NUMBER IS (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    274804 BONE WAX 24X2.5G BONE WAZ MTJ B. BRAUN SURGICAL S.A. 1029754 213424

    Patients

    Seq Age Sex Outcome Treatment
    1 Other