BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    X-FLOW PROSTATECTOMY CATHETER

    MDR report key: 18651241 · Received February 6, 2024

    Report

    Report Number
    9610711-2024-00028
    Event Type
    Malfunction
    Date Received
    February 6, 2024
    Date of Event
    December 25, 2023
    Report Date
    June 4, 2024
    Manufacturer
    COLOPLAST A/S
    Product Code
    EZL
    UDI-DI
    03600040144312
    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 FOUND NONE ON THE LOT 9240224. THE PROBABLE ROOT CAUSE OF THIS ISSUE WAS A PROBLEM WITH BALLOON¿S RAW MATERIAL. CHECKING THE QUALITY DATABASES REVEALED THIS TYPE OF DEFECT IS KNOWN AND CLOSELY /SPECIFICALLY MONITORED. A SIMILAR CASE STUDY WAS PERFORMED BASED ON SAME ITEM NUMBER AND SAME DEFECT [BALLOON BURST] OVER LAST FOUR YEARS, 57 SIMILAR CASES WERE FOUND. A RISK MANAGEMENT FRAMEWORK EVALUATION WAS PERFORMED 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. CORRECTION: B5: EVENT DESCRIPTION.

    Description of Event or Problem · 0

    ACCORDING TO THE AVAILABLE INFORMATION THE BALLOON BURST ON TWO OCCASIONS. THERE WERE NO CLINICAL CONSEQUENCES BUT PAIN AND DISCOMFORT FOR THE PATIENT.

    Description of Event or Problem · 0

    ACCORDING TO THE AVAILABLE INFORMATION THE PATIENT WAS CATHETERIZED. NO CLINICAL CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    482262 X-FLOW PROSTATECTOMY CATHETER INDWELLING URETHRAL DRAINAGE BALLOON CATHETER, NON-ANTIMICROBIAL EZL COLOPLAST A/S 789789789 9240224_AB63201002 03600040144312

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown