BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEKNATEL BON GN BR 2-0 C-2/CST-43

    MDR report key: 3834540 · Received March 19, 2014

    Report

    Report Number
    3004365956-2014-00138
    Event Type
    Malfunction
    Date Received
    March 19, 2014
    Date of Event
    December 19, 2013
    Report Date
    March 3, 2014
    Manufacturer
    TELEFLEX
    Product Code
    GAK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORD (DHR) HAS BEEN REVIEWED AND NO ISSUES OR DISCREPANCIES WERE FOUND WHICH COULD POTENTIALLY RELATE TO THIS COMPLAINT. DHR SHOWS THAT THE PRODUCT WAS ASSEMBLED AND INSPECTED ACCORDING TO OUR SPECIFICATIONS. NO SAMPLE IS AVAILABLE FOR EVALUATION AT TIME OF THIS REPORT.

    Description of Event or Problem · 1

    COMPLAINT ALLEGES: TIP OF THE SUTURE BROKE AND REMAINED IN THE PATIENT. AN X-RAY WAS REQUIRED TO FIND AND REMOVE THE TIP OF THE SUTURE. IT WAS SUCCESSFULLY REMOVED. THERE WAS NO PATIENT INJURY REPORTED AND THE PATIENT'S CURRENT CONDITION IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    162268 DEKNATEL BON GN BR 2-0 C-2/CST-43 CAPIO SUTURE GAK TELEFLEX 02F1300563

    Patients

    Seq Age Sex Outcome Treatment
    1