BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESONANCE STENT SET

    MDR report key: 21823928 · Received April 11, 2025

    Report

    Report Number
    3005580113-2025-00025
    Event Type
    Injury
    Date Received
    April 11, 2025
    Date of Event
    January 4, 2021
    Report Date
    March 17, 2025
    Manufacturer
    COOK MEDICAL IRELAND
    Product Code
    FAD
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    AS REPORTED TO CUSTOMER RELATIONS VIA CRI OBSERVATION STUDY COMPLAINT FORM: ON (B)(6) 2020 A CYSTOSCOPY WITH SUCCESSFUL STENT PLACEMENT WAS DONE DUE TO RIGHT URETERAL OBSTRUCTION. THE STENT WAS PLACED IN THE RIGHT URETER WITH RETROGRADE ACCESS. AFTER THE INDEX PROCEDURE THE PATIENT DEVELOPED ACUTE KIDNEY INJURY AND ON (B)(6) 2021 (131 DAYS POST PROCEDURE) A CYSTOSCOPY WAS PERFORMED WHICH SHOWED THE STENT HAD DISTALLY MIGRATED. ON (B)(6) 2021 (163 DAYS POST PROCEDURE) THE STENT WAS REPLACED WITH A LONGER ONE (RMS-060026-R).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2379038 RESONANCE STENT SET FAD STENT, URETERAL FAD COOK MEDICAL IRELAND G34110

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Male Required Intervention