BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    X-FLOW PROSTATECTOMY CATHETER

    MDR report key: 19255603 · Received May 6, 2024

    Report

    Report Number
    9610711-2024-00105
    Event Type
    Malfunction
    Date Received
    May 6, 2024
    Date of Event
    March 25, 2024
    Report Date
    October 2, 2024
    Manufacturer
    COLOPLAST A/S
    Product Code
    EZL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    ONE NON-CONFORMITY IN RELATION TO THE DESCRIBED DEFECT AND A CORRECTIVE AND PREVENTIVE ACTION.

    Additional Manufacturer Narrative · 0

    AFTER RECEIVING THIS COMPLAINT, WE SEARCHED FOR OTHER COMPLAINTS AND WE FOUND NONE REGARDING THE LOT NUMBER 9112154 WITH THE SAME DEFECT. A SIMILAR CASE STUDY BASED ON ITEM NUMBER AB6R, DEFECT BURST, OVER LAST FOUR YEAR: FOUR SIMILAR CASES WERE FOUND (B)(4). UNFORTUNATELY, WITHOUT SAMPLE WE CANNOT GO FURTHER THAN THE DOCUMENTARY INVESTIGATION ON THE INTERMEDIATE PRODUCT AB6R2480 LOT NUMBER 8945840 WHICH DIDN¿T REVEAL ANY ANOMALY RECORDED DURING PRODUCTION.

    Description of Event or Problem · 0

    ACCORDING TO THE AVAILABLE INFORMATION THE PATIENT TWICE LOST HIS CATHETER THAT BURST. PATIENT EXPERIENCED HEMATURIA AND PAIN.

    Description of Event or Problem · 0

    ACCORDING TO THE AVAILABLE INFORMATION THE PATIENT TWICE LOST HIS CATHETER THAT BURST. PATIENT EXPERIENCED HEMATURIA AND PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    599553 X-FLOW PROSTATECTOMY CATHETER INDWELLING URETHRAL DRAINAGE BALLOON CATHETER, NON-ANTIMICROBIAL EZL COLOPLAST A/S 9112154_AB6R241002

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention