BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MONOMAX VIOLET 1(4) 150CM HRN50 LOOP (M)

    MDR report key: 3880716 · Received May 28, 2014

    Report

    Report Number
    2916714-2014-00413
    Event Type
    Malfunction
    Date Received
    May 28, 2014
    Report Date
    May 28, 2014
    Manufacturer
    B. BRAUN SURGICAL S.A.
    Product Code
    NWJ
    PMA / PMN Number
    K100876
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    US REPORTING AGENT NOTIFIED ON (B)(6) 2014. MANUFACTURING SITE EVALUATION: SAMPLES RECEIVED: 3 UNOPENED POUCHES THERE ARE NO PREVIOUS COMPLAINTS OF THIS CODE/BATCH. THERE ARE NO UNITS IN OEM STOCK. ALL PACKS RECEIVED ARE TIGHT. TESTED THE KNOT PULL TENSILE STRENGTH OF THE SAMPLE RECEIVED AND THE RESULTS FULFIL THE REQUIREMENTS OF THE OEM. KNOT PULL TENSILE STRENGTH RESULTS BEFORE RELEASING THE PRODUCT WERE FULFILLED OEM REQUIREMENTS. REVIEWED THE BATCH MANUFACTURING RECORD, THIS PRODUCT HAD A NORMAL PROCESS AND THE RESULTS DURING THE PROCESS FULFILS OEM REQUIREMENTS. FINAL CONCLUSION: THE COMPLAINT IS NOT CORRESPONDING (NOT JUSTIFIED). CORRECTIVE/PREVENTIVE ACTIONS: NOT APPLICABLE.

    Description of Event or Problem · 1

    COUNTRY OF COMPLAINT: (B)(6). THREAD BREAKS DURING KNOTTING. QUESTIONING IF THREAD IS A "0" INSTEAD OF A "1" AS IT SEEMS THINNER THAN IT SHOULD BE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    313868 MONOMAX VIOLET 1(4) 150CM HRN50 LOOP (M) SYNTHETIC ABSORBABLE SUTRUE NWJ B. BRAUN SURGICAL S.A. B0041166 114042

    Patients

    Seq Age Sex Outcome Treatment
    1 Other