BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEKNATEL TEV TRI BR 2-0 KT-3 30"X9 PFM

    MDR report key: 4240081 · Received November 4, 2014

    Report

    Report Number
    3004365956-2014-00383
    Event Type
    Malfunction
    Date Received
    November 4, 2014
    Date of Event
    September 5, 2014
    Report Date
    October 10, 2014
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    OVN
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE HISTORY RECORD (DHR) SHOWS THAT THE PRODUCT WAS ASSEMBLED AND INSPECTED ACCORDING TO MANUFACTURER'S SPECIFICATIONS. DEVICE SAMPLE RECEIVED BY MANUFACTURER, BUT INVESTIGATION IS STILL UNDERWAY AT TIME OF THIS REPORT.

    Description of Event or Problem · 1

    COMPLAINT ALLEGES: IT WAS REPORTED THAT DURING AN AORTIC VALVE REPLACEMENT PROCEDURE, WHILE TYING THE STITCHES DOWN, THEY BROKE. THE SURGEON REPLACED THE SUTURES AND FINISHED THE CASE. THERE WAS NO HARM TO THE PATIENT AND NO MEDICAL INTERVENTION WAS REQUIRED. THE PATIENT IS IN STABLE CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    708208 DEKNATEL TEV TRI BR 2-0 KT-3 30"X9 PFM NEEDLE OVN TELEFLEX MEDICAL 02A1401018

    Patients

    Seq Age Sex Outcome Treatment
    1