BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    X-FLOW PROSTATECTOMY CATHETER

    MDR report key: 19127027 · Received April 17, 2024

    Report

    Report Number
    9610711-2024-00085
    Event Type
    Malfunction
    Date Received
    April 17, 2024
    Date of Event
    March 19, 2024
    Report Date
    July 31, 2024
    Manufacturer
    COLOPLAST A/S
    Product Code
    EZL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    B3: ESTIMATED DATE. AFTER RECEIVING THIS COMPLAINT, WE SEARCHED FOR OTHER COMPLAINTS AND WE DIDN'T FIND ANY OTHER COMPLAINTS REGARDING THE LOT NUMBER 9112313. WE RECEIVED 2 PHOTOS AND ONE HAIR WAS OBSERVED INSIDE THE INNER PACKAGING. CHECKING THE QUALITY DATABASES DID NOT REVEAL ANY ANOMALY IN RELATION TO THE DESCRIBED DEFECT. WE RECEIVED INVESTIGATION FROM OUR SUBCONTRACTOR: "ACTIONS HAVE BEEN PUT IN PLACE SINCE (B)(6) 2021 CONCERNING THE PRESENCE OF HAIR (REINFORCED CONTROL BEFORE AND AFTER SHEATHING AND BEFORE AND AFTER THE CORKING ROPE) AND ITS ACTIONS ARE CARRIED OUT UNTIL TODAY" IN ADDITION, OUR SUBCONTRACTOR HAS RE-SENSITIZED PRODUCTION OPERATORS ABOUT "HAIR PRESENCE AND DECONTAMINATION" IN (B)(6) 2023.

    Description of Event or Problem · 0

    ACCORDING TO THE AVAILABLE INFORMATION A FOREIGN OBJECT WAS FOUND INSIDE THE PACKAGING. A NEW DEVICE WAS USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1868553 X-FLOW PROSTATECTOMY CATHETER INDWELLING URETHRAL DRAINAGE BALLOON CATHETER, NON-ANTIMICROBIAL EZL COLOPLAST A/S 9112313_AB63221002

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown