BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEK BL MF 0 TC-43/HR 26 2N

    MDR report key: 9083692 · Received September 18, 2019

    Report

    Report Number
    3004365956-2019-00261
    Event Type
    Malfunction
    Date Received
    September 18, 2019
    Date of Event
    August 6, 2019
    Report Date
    August 28, 2019
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    GAW
    PMA / PMN Number
    K930738
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    QN#(B)(4). NO ISSUES OR DISCREPANCIES WERE FOUND IN THE DEVICE HISTORY RECORD OF PRODUCT CODE 833-124 / BATCH 74D1902255 THAT CAN BE RELATED TO THE FAILURE MODE REPORTED. A CORRECTIVE ACTION CANNOT BE IMPLEMENTED AT THE TIME SINCE THE SAMPLE INVOLVED IN THE CUSTOMER COMPLAINT WAS NOT SENT FOR ANALYSIS. CUSTOMER COMPLAINT CANNOT BE CONFIRMED SINCE THE PRODUCT INVOLVED IN THE COMPLAINT NOTIFICATION WAS NOT PROVIDED TO PERFORM A PROPER INVESTIGATION. ONCE THAT THE SAMPLE BECOME AVAILABLE THIS COMPLAINT REPORT WILL BE UPDATED ACCORDINGLY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING THE PROCEDURE THE SUTURE REVENTED. SUTURE WAS BROKEN.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HAS NOT BEEN RETURNED FOR INVESTIGATION. TELEFLEX WILL CONTINUE TO MONITOR AND TREND RELATED EVENTS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE PROCEDURE THE SUTURE REVENTED. SUTURE WAS BROKEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    878414 DEK BL MF 0 TC-43/HR 26 2N SUTURE, NONABSORBABLE, SYNTHE GAW TELEFLEX MEDICAL 74D1902255

    Patients

    Seq Age Sex Outcome Treatment
    1