BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MONOMAX VIOLET 1(4) 150CM HRT48 LOOP (M)

    MDR report key: 3821481 · Received January 15, 2014

    Report

    Report Number
    2916714-2014-00038
    Event Type
    Malfunction
    Date Received
    January 15, 2014
    Report Date
    January 15, 2014
    Manufacturer
    B. BRAUN SURGICAL S.A.
    Product Code
    GAL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    US REPORTING AGENT NOTIFIED ON (B)(4) 2013. REPORTED DEVICE NOT MARKETED IN THE US; HOWEVER, SIMILAR DEVICE IS. MANUFACTURING SITE EVALUATION: SAMPLES RECEIVED: 1 UNOPENED BOX WITH 24 POUCHES. REVIEWED THE BATCH MANUFACTURING RECORD, THIS PRODUCT HAD A NORMAL PROCESS AND THE RESULTS DURING THE PROCESS FULFIL OEM REQUIREMENTS. THERE ARE NO PREVIOUS COMPLAINTS OF THIS CODE/BATCH. THERE ARE NO UNITS IN OEM STOCK. ALL PACKS RECEIVED ARE TIGHT. KNOT PULL TENSILE STRENGTH OF THE SAMPLES RECEIVED WAS TESTED AND THE RESULTS FULFIL THE REQUIREMENTS OF THE OEM. KNOT PULL TENSILE STRENGTH RESULTS BEFORE RELEASING THE PRODUCT WERE IN ACCORDANCE WITH OEM SPECIFICATION. FINAL CONCLUSION: THE COMPLAINT IS NOT CORRESPONDING (NOT JUSTIFIED).

    Description of Event or Problem · 1

    COUNTRY OF COMPLAINT: (B)(6). THREAD BREAKS OFTEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    40963 MONOMAX VIOLET 1(4) 150CM HRT48 LOOP (M) NONE GAL B. BRAUN SURGICAL S.A. B0041222 112464V004

    Patients

    Seq Age Sex Outcome Treatment
    1 Other