BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    X-FLOW PROSTATECTOMY CATHETER

    MDR report key: 18132438 · Received November 14, 2023

    Report

    Report Number
    9610711-2023-00246
    Event Type
    Malfunction
    Date Received
    November 14, 2023
    Date of Event
    October 11, 2023
    Report Date
    May 21, 2024
    Manufacturer
    COLOPLAST A/S
    Product Code
    EZL
    UDI-DI
    03600040143629
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE LOT NUMBER WAS REPORTED TO BE ONE OF THE FOLLOWING LOTS: 8341166, 8765612, 8559602, 9102872 OR 8839826. THE SPECIFIC LOT INVOLVED WAS UNKNOWN.

    Additional Manufacturer Narrative · 0

    AFTER RECEIVING THIS COMPLAINT, WE SEARCHED FOR OTHER COMPLAINTS AND WE FOUND NONE REGARDING THE LOT NUMBER 8341166. IN OCTOBER, WE RECEIVED ONE USED SAMPLE WITH BALLOON BURST. AFTER DISINFECTION WE NOTICED THAT THE BALLOON WAS BURST. A SIMILAR CASE STUDY WAS PERFORMED BASED ON SAME ITEM NUMBER AB61, SAME DEFECT: BALLOON BURST, OVER LAST FOUR YEAR; 5 SIMILAR CASES WERE FOUND.

    Description of Event or Problem · 0

    ACCORDING TO THE AVAILABLE INFORMATION AFTER PLACEMENT OF THE CATHETER, AFTER SURGERY, THE BALLOON RUPTURED. A SECOND CATHETER WAS PLACED; HOWEVER, THIS BALLOON ALSO RUPTURED. THE PATIENT EXPERIENCED PAIN DURING REMOVAL OF EACH CATHETER, AND ALSO EXPERIENCED URINARY RETENTION.

    Description of Event or Problem · 0

    ACCORDING TO THE AVAILABLE INFORMATION AFTER PLACEMENT OF THE CATHETER, AFTER SURGERY, THE BALLOON RUPTURED. A SECOND CATHETER WAS PLACED; HOWEVER, THIS BALLOON ALSO RUPTURED. THE PATIENT EXPERIENCED PAIN DURING REMOVAL OF EACH CATHETER, AND ALSO EXPERIENCED URINARY RETENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2027201 X-FLOW PROSTATECTOMY CATHETER INDWELLING URETHRAL DRAINAGE BALLOON CATHETER, NON-ANTIMICROBIAL EZL COLOPLAST A/S 8839826_AB61181002 03600040143629

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown