BEUDAMED
    FDA Adverse Event Injury Summary report: N

    X-FLOW PROSTATECTOMY CATHETER

    MDR report key: 18791952 · Received February 27, 2024

    Report

    Report Number
    9610711-2024-00046
    Event Type
    Injury
    Date Received
    February 27, 2024
    Date of Event
    January 15, 2024
    Report Date
    July 2, 2024
    Manufacturer
    COLOPLAST A/S
    Product Code
    EZL
    UDI-DI
    03600040143360
    Adverse Event
    Yes
    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 DIDN'T FIND ANY OTHER COMPLAINT REGARDING THE LOT NUMBER 9213522. CHECKING THE QUALITY DATABASES REVEALED THIS TYPE OF DEFECT IS KNOWN AND CLOSELY MONITORED. A SIMILAR CASE STUDY BASED ON ITEM NUMBER AB60XX AND DEFECT "BALLOON BURST", OVER THE LAST FOUR YEARS: 3 SIMILAR CASES WERE FOUND. A RISK MANAGEMENT FILE EVALUATION WAS DONE AND CONCLUDED THAT RESIDUAL RISKS ARE ADEQUATELY CONTROLLED AND REDUCED AS FAR AS POSSIBLE, AND THE RESIDUAL RISKS ASSOCIATED WITH THE USE OF THE PRODUCT ARE ACCEPTABLE WHEN WEIGHED AGAINST THE BENEFITS TO THE PATIENT/USER. IT IS CONCLUDED THAT THE RISKS IDENTIFIED ARE STILL ACCEPTABLE AND CONSIDERED AS SAFE.

    Description of Event or Problem · 0

    ACCORDING TO THE AVAILABLE INFORMATION THE CATHETER TORE AND THE BALLOON BURST. THE PATIENT EXPERIENCED SIGNIFICANT BLEEDING AND REQUIRED INTERVENTION. A NEW CATHETER WAS PLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1657287 X-FLOW PROSTATECTOMY CATHETER INDWELLING URETHRAL DRAINAGE BALLOON CATHETER, NON-ANTIMICROBIAL EZL COLOPLAST A/S 9213522_AB60221002 03600040143360

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention