BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SILKAM BLACK 3/0 (2) 75CM HS26

    MDR report key: 4992715 · Received August 7, 2015

    Report

    Report Number
    2916714-2015-00679
    Event Type
    Malfunction
    Date Received
    August 7, 2015
    Report Date
    August 5, 2015
    Manufacturer
    B. BRAUN SURGICAL S. A.
    Product Code
    GAP
    PMA / PMN Number
    K990089
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MFR SITE EVAL: SAMPLES RECEIVED: 6 UNOPENED POUCHES. ANALYSIS AND RESULTS. THERE ARE NO PREVIOUS COMPLAINTS OF THIS CODE BATCH; (B)(4) UNITS OF THIS CODE BATCH WERE MANUFACTURED AND DISTRIBUTED; THERE ARE NO UNITS IN STOCK. RECEIVED SIX CLOSED SAMPLES. TESTED THE KNOT PULL TENSILE STRENGTH OF THE SAMPLES RECEIVED AND THE RESULTS FULFILL THE OEM REQUIREMENTS. REVIEWED THE BATCH MFG RECORD, THIS PRODUCT HAD A NORMAL PROCESS AND THE RESULTS DURING THE PROCESS FULFILL THE OEM REQUIREMENTS. FINAL CONCLUSION: COMPLAINT IS NOT JUSTIFIED. CORRECTIVE/PREVENTIVE ACTIONS: NA.

    Description of Event or Problem · 1

    COUNTRY OF COMPLAINT: (B)(6). THE SUTURE IS BREAKING WHEN KNOTTING. THIS IS 3 OF 3. (REF MDR 2916714-2015-00677, 00678.)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    521037 SILKAM BLACK 3/0 (2) 75CM HS26 SUTURES GAP B. BRAUN SURGICAL S. A. C0762415 615041

    Patients

    Seq Age Sex Outcome Treatment
    1 Other