BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BALLOON URETHRAL DILATOR

    MDR report key: 2934574 · Received January 24, 2013

    Report

    Report Number
    2934574
    Event Type
    Malfunction
    Date Received
    January 24, 2013
    Date of Event
    December 21, 2012
    Report Date
    January 24, 2013
    Manufacturer
    COOK, INC.
    Product Code
    EZN
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MN, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PROCEDURE: CYSTOSCOPY, RETROGRADES, RIGHT URETEROSCOP, RIGHT URETRAL STENT PLACEMENT.THE END OF THE BALLOON URETERAL DILATOR AND PART OF THE BALLOON BROKE OFF IN THE PATIENT'S RIGHT URETER. THE BROKEN PIECE WAS RETRIEVED WITH A GRASPER SINCE IT WAS NEAR THE URETERAL OPENING. NO ADVERSE OUTCOME TO THE PATIENT. THE RETRIEVED PIECE WAS RETURNED TO THE MANUFACTURER FOR AN EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    34551 BALLOON URETHRAL DILATOR DILATOR, CATHETER, URETERAL EZN COOK, INC. G14261 U2254267

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR