BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 3963498 · Received June 16, 2014

    Report

    Report Number
    3004365956-2014-00227
    Event Type
    Malfunction
    Date Received
    June 16, 2014
    Date of Event
    May 15, 2014
    Report Date
    May 26, 2014
    Manufacturer
    TELEFLEX
    Product Code
    GAO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    NURSE

    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. NO REJECTION REPORT WERE ORIGINATED FOR THE LOT IN QUESTION THAT CAN BE ASSOCIATED TO THE COMPLAINT REPORTED. DHR SHOWS THAT THE PRODUCT WAS ASSEMBLED ADN INSPECTED ACCORDING TO OUR SPECS. NO CORRECTIVE ACTIONS CAN BE ESTABLISHED SINCE IT IS NECESSARY TO RECEIVE THE PHYSICAL SAMPLE TO PERFORM A PROPER INVESTIGATION AND CONFIRM THE DEFECT. AT THIS TIME DUE TO THE LACK OF DEFECTIVE PRODUCT IS NOT POSSIBLE TO DETERMINE THE SOURCE OF THE DEFECT REPORTED. CUSTOMER COMPLAINT CAN NOT BE CONFIRMED DUE THE LACK OF PRODUCT SAMPLE TO PERFORM A PROPER INVESTIGATION AND DETERMINE THE ROOT CAUSE. HOWEVER, THE MFR WILL CONTINUE TO MONITOR AND TREND RELATING COMPLAINTS.

    Description of Event or Problem · 1

    THE EVENT IS REPORTED AS: COMPLAINT ALLEGED ISSUE: IT WAS REPORTED THAT DURING SACROSPINOUS FIXATION (SSF) "AFTER CUTTING THE SUTURE BY THE DOCTOR, THE NURSE NOTICED THAT SUTURE WAS SPLIT." PT HAS NOT COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    353251 DEKNATEL DEK BL MF 0 TC-43/HR 26 2N SUTURE GAO TELEFLEX 02C1300770

    Patients

    Seq Age Sex Outcome Treatment
    1