BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAGROFIL GREEN 5 (7) 25M

    MDR report key: 3821464 · Received January 14, 2014

    Report

    Report Number
    2916714-2014-00024
    Event Type
    Malfunction
    Date Received
    January 14, 2014
    Report Date
    January 14, 2014
    Manufacturer
    B. BRAUN SURGICAL S.A.
    Product Code
    MPN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    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 CASSETTE. 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. KNOT PULL TENSILE STRENGTH OF THE SAMPLE RECEIVED WAS TESTED AND RESULTS FULFIL THE REQUIREMENTS OF THE OEM. FINAL CONCLUSION: THE COMPLAINT IS NOT CORRESPONDING (NOT JUSTIFIED). ACTIONS ON PRODUCT: NOT APPLICABLE. CORRECTIVE/PREVENTIVE ACTIONS: NOT APPLICABLE.

    Description of Event or Problem · 1

    COUNTRY OF COMPLAINT: (B)(6). EACH TIME THE VET WAS PUTTING TENSION ON THE SUTURE THE WIRE WAS BREAKING. TISSUE WHERE THE SUTURE WAS IMPLANTED: SKIN. TYPE OF SUTURING TECHNIQUE EMPLOYED: INTERRUPTED. TYPE OF OPERATION: SECTION/CAESAREAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    37507 DAGROFIL GREEN 5 (7) 25M NONE MPN B. BRAUN SURGICAL S.A. F1244116 612521

    Patients

    Seq Age Sex Outcome Treatment
    1 Other