BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 10033161 · Received May 7, 2020

    Report

    Report Number
    3004365956-2020-00107
    Event Type
    Malfunction
    Date Received
    May 7, 2020
    Date of Event
    April 1, 2020
    Report Date
    April 21, 2020
    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 · 1

    (B)(4). A FUNCTIONAL INSPECTION OF THE PRODUCT INVOLVED COULD NOT BE CONDUCTED SINCE THE PRODUCT WAS NOT SENT FOR ANALYSIS. NO ADDITIONAL TESTS WERE PERFORMED AS PART OF THIS INVESTIGATION SINCE PRODUCT CODE 833-124 IS NOT CURRENTLY IN PRODUCTION. NO ISSUES OR DISCREPANCIES WERE FOUND IN THE DEVICE HISTORY RECORD OF PRODUCT CODE 833-124 / BATCH 74J1900535 THAT CAN BE RELATED TO THE FAILURE MODE REPORTED. NO CORRECTIVE ACTION CAN BE IMPLEMENTED DUE TO THE LACK OF PRODUCT SAMPLE TO PERFORM A PROPER INVESTIGATION TO DETERMINE A ROOT CAUSE. THE CUSTOMER COMPLAINT CANNOT BE CONFIRMED DUE TO THE LACK OF PRODUCT SAMPLE TO PERFORM A PROPER INVESTIGATION AND DETERMINE A ROOT CAUSE. TELEFLEX WILL CONTINUE TO MONITOR AND TREND RELATED EVENTS.

    Description of Event or Problem · 1

    THE REPORT STATES: PLEASE NOTE THAT ON (B)(6) 2020 IT WAS NOTED THAT THE NEEDLE BROKE UPON INSERTION DURING A PUBOVAGINAL SLING PLACEMENT AND SUBSEQUENTLY DETACHED IN THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    498421 DEK BL MF 0 TC-43/HR 26 2N SUTURE, NONABSORBABLE, SYNTHE GAW TELEFLEX MEDICAL 74J1900535

    Patients

    Seq Age Sex Outcome Treatment
    1