BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SILKAM BLACK 4/0 (1.5) 45CM HS18

    MDR report key: 3850449 · Received March 18, 2014

    Report

    Report Number
    2916714-2014-00140
    Event Type
    Malfunction
    Date Received
    March 18, 2014
    Report Date
    March 17, 2014
    Manufacturer
    B BRAUN SURGICAL S.A.
    Product Code
    GAP
    PMA / PMN Number
    K990089
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MFG SITE EVAL: SAMPLES RECEIVED - 1 CLOSED SAMPLE AND 1 OPEN SAMPLE WITH THE THREAD BROKEN (USED). THERE ARE NO PREVIOUS COMPLAINTS OF THIS CODE/BATCH. THERE ARE NO UNITS IN OEM STOCK. WE HAVE TESTED THE KNOT PULL TENSILE STRENGTH OF CLOSED SAMPLE RECEIVED AND THE RESULT FULFIL THE REQUIREMENTS OF THE OEM. REVIEWED THE BATCH MFG RECORD, THIS PRODUCT HAD A NORMAL PROCESS AND THE RESULTS DURING THE PROCESS FULFIL OEM REQUIREMENTS. FINAL CONCLUSION: THE COMPLAINT IS NOT CORRESPONDING (NOT JUSTIFIED).

    Description of Event or Problem · 1

    COUNTRY OF COMPLAINT: (B)(6). THREAD CRACKED WHILE SUTURING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    159733 SILKAM BLACK 4/0 (1.5) 45CM HS18 SILK NON-ABSORBABLE SUTURE GAP B BRAUN SURGICAL S.A. G0762563 612473V004

    Patients

    Seq Age Sex Outcome Treatment
    1 Other