BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UROLIFT 2 IMPLANT CARTRIDGE

    MDR report key: 23065855 · Received September 16, 2025

    Report

    Report Number
    3015181082-2025-00055
    Event Type
    Malfunction
    Date Received
    September 16, 2025
    Date of Event
    August 19, 2025
    Report Date
    August 19, 2025
    Manufacturer
    NEOTRACT, INC.
    Product Code
    PEW
    PMA / PMN Number
    K201837
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    QN# (B)(4). COMPLAINT VERIFICATION TESTING COULD NOT BE PERFORMED AS NO SAMPLE WAS RETURNED FOR ANALYSIS. WITHOUT THE DEVICE TO EVALUATE, THE COMPLAINT COULD NOT BE CONFIRMED, AND THE PROBABLE CAUSE COULD NOT BE DETERMINED FROM THE AVAILABLE INFORMATION. TELEFLEX WILL CONTINUE TO MONITOR AND TREND FOR REPORTS OF THIS NATURE.

    Additional Manufacturer Narrative · 0

    (B)(4)

    Description of Event or Problem · 0

    IT WAS REPORTED "BLADDER IS IN RETENTION, EXTREME BURNING, NO BOWEL MOVEMENT IN 5 DAYS AND PNEUMONIA ADMITTED TO THE HOSPITAL. HE HAS A VERY NARROW CHANNEL WITH DIFFICULTY OPENING. PHYSICIAN HAD A TIGHT BLADDER NECK. HE ALSO HAD ONE CLIP THAT VERY CLOSE TO THE BLADDER MAKING IT TIGHT TO MOVE DEVICE. ONE CLIP WAS IMPLANTED CLOSE TO THE BLADDER NECK". THE PATIENT'S CURRENT CONDITION IS REPORTED AS "UNKNOWN". ASSOCIATED MDR#S: 3015181082-2025-00054, 3015181082-2025-00055, 3015181082-2025-00056, AND 3015181082-2025-00057.

    Description of Event or Problem · 0

    IT WAS REPORTED "BLADDER IS IN RETENTION, EXTREME BURNING, NO BOWEL MOVEMENT IN 5 DAYS AND PNEUMONIA ADMITTED TO THE HOSPITAL. HE HAS A VERY NARROW CHANNEL WITH DIFFICULTY OPENING. PHYSICIAN HAD A TIGHT BLADDER NECK. HE ALSO HAD ONE CLIP THAT VERY CLOSE TO THE BLADDER MAKING IT TIGHT TO MOVE DEVICE. ONE CLIP WAS IMPLANTED CLOSE TO THE BLADDER NECK". THE PATIENT'S CURRENT CONDITION IS REPORTED AS "UNKNOWN". PLEASE SEE ASSOCIATED MDR#S: 3015181082-2025-00054, 3015181082-2025-00056, 3015181082-2025-00057.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2673378 UROLIFT 2 IMPLANT CARTRIDGE IMPLANTABLE TRANSPROSTATIC TIS PEW NEOTRACT, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown