BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SINGLE LOOP URETERAL STENT

    MDR report key: 19559364 · Received June 18, 2024

    Report

    Report Number
    9610711-2024-00147
    Event Type
    Malfunction
    Date Received
    June 18, 2024
    Date of Event
    May 1, 2024
    Report Date
    December 31, 2024
    Manufacturer
    COLOPLAST A/S
    Product Code
    FAD
    UDI-DI
    03600040160343
    PMA / PMN Number
    K201436
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE REVIEW OF THE COMPLAINT HISTORY DATABASE, REVEALED NO TRENDS FOR THE LOT NUMBER 9634730. OUR PACKAGING SITE MADE AN INVESTIGATION WHICH CONCLUDE: "ACCIDENTIAL - RANDOM ISSUE; THE FLY HAVE NOT BEEN DETECTED AT PACKAGING INSPECTION. ALL RELEVANT PROCEDURE HAVE BEEN KEPT EVEN SO THIS ISSUE HAPPENED AND THE COMPLAINT WAS RECEIVED. THE RELEVANT PESTCONTROL INSTRUCTION WAS CHECKED, NO UPDATE IS NEEDED; VV-0180198 V.11.0 - CONTROL OF FACILITY IN COLOPLAST TAT. THE PRODUCTION SITE OF URINEBAG VS HAS BEEN INFORMED ABOUT THIS ISSUE. THEY WILL FOCUS TO FILTER OUT THE FLY OR OTHER FOREIGN MATERIAL TAINTED PRODUCTS IN THE FUTURE. BY QUALITY POINT OF VIEW OTHER ACTION IS NOT NEEDED." ACCORDING TO THE ELEMENTS KNOWN, QUALITY DATABASE WAS CHECKED AND REVEALED NO ANOMALY IN RELATION TO THE DESCRIBE DEFECT, HOWEVER THE DEFECT WAS OBSERVED.

    Additional Manufacturer Narrative · 0

    B3: ESTIMATED DATE.

    Description of Event or Problem · 0

    ACCORDING TO THE AVAILABLE INFORMATION A FLY WAS FOUND WRAPPED IN THE PACKAGING. THE DEVICE WAS NOT USED.

    Description of Event or Problem · 0

    ACCORDING TO THE AVAILABLE INFORMATION A FLY WAS FOUND WRAPPED IN THE PACKAGING. THE DEVICE WAS NOT USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2310701 SINGLE LOOP URETERAL STENT POLYMERIC URETERAL STENT FAD COLOPLAST A/S 9634730_ACA1071002 03600040160343

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown