BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    X-FLOW PROSTATECTOMY CATHETER

    MDR report key: 21491613 · Received February 28, 2025

    Report

    Report Number
    9610711-2025-00041
    Event Type
    Malfunction
    Date Received
    February 28, 2025
    Date of Event
    February 6, 2025
    Report Date
    February 28, 2025
    Manufacturer
    COLOPLAST A/S
    Product Code
    EZL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AFTER RECEIVING THIS COMPLAINT, WE SEARCHED FOR OTHER COMPLAINTS AND WE FOUND NONE REGARDING THE LOT NUMBER 9920644. THE INVESTIGATION IS NOT YET COMPLETE, A FOLLOW UP REPORT WILL BE SUBMITTED ON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 0

    ACCORDING TO THE AVAILABLE INFORMATION, DURING INFLATION OF THE BALLOON WITH WATER, A DULL NOISE WAS HEARD AND THE PATIENT SCREAMED. THE CATHETER WAS REMOVED FROM THE PATIENT AND NOTICED THE DEFLATED (BURST) BALLOON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    660947 X-FLOW PROSTATECTOMY CATHETER INDWELLING URETHRAL DRAINAGE BALLOON CATHETER, NON-ANTIMICROBIAL EZL COLOPLAST A/S 9920644_AB62181002

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown