BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UROLIFT 2 IMPLANT CARTRIDGE

    MDR report key: 22903720 · Received August 27, 2025

    Report

    Report Number
    3015181082-2025-00027
    Event Type
    Malfunction
    Date Received
    August 27, 2025
    Date of Event
    December 26, 2024
    Report Date
    August 5, 2025
    Manufacturer
    NEOTRACT, INC.
    Product Code
    PEW
    PMA / PMN Number
    K201837
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4).

    Additional Manufacturer Narrative · 0

    (B)(4) COMPLAINT VERIFICATION TESTING COULD NOT BE PERFORMED AS NO SAMPLE WAS RETURNED FOR ANALYSIS. A DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED, AS A LOT NUMBER WAS NOT REPORTED. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED " THE PATIENT HAD THE FIRST UROLIFT PROCEDURE ON (B)(6) 2023, BUT HIS URINARY RETENTION WAS NOT RESOLVED. A FLEXIBLE ENDOSCOPY WAS PERFORMED SIX MONTHS AFTER THE FIRST UROLIFT PROCEDURE AND ONE CAPSULAR TAB FROM THE RIGHT LOBE NECK WAS FOUND INSIDE THE BLADDER. THE PATIENT HAD URETHRAL STENOSIS SO A STANDARD RIGID ENDOSCOPE COULD NOT BE PASSED THROUGH THE URETHRA. THE WAS MILD FOREIGN BODY FORMATION ON THE CAPSULAR TAB. THEREFORE, THE DOCTOR DECIDED TO OBSERVE THE PROGRESS WITHOUT REMOVING THE IMPLANT. THE PATIENT HAD THE SECOND UROLIFT PROCEDURE ON (B)(6) 2024, BUT HIS URINARY RETENTION WAS NOT RESOLVED. A FLEXIBLE ENDOSCOPY WAS PERFORMED ON (B)(6) 2025, HIS URINARY RETENTION WAS NOT RESOLVED, AND IT WAS FOUND THAT STONES ARE ATTACHED TO THE CAPSULAR TAB. THEREFORE, THE IMPLANTS ARE SCHEDULED TO BE REMOVED ON (B)(6) 2025". THE PATIENTS CURRENT CONDITION IS REPORTED AS "UNKNOWN".

    Description of Event or Problem · 0

    IT WAS REPORTED " THE PATIENT HAD THE FIRST UROLIFT PROCEDURE ON (B)(6) 2023, BUT HIS URINARY RETENTION WAS NOT RESOLVED. A FLEXIBLE ENDOSCOPY WAS PERFORMED SIX MONTHS AFTER THE FIRST UROLIFT PROCEDURE AND ONE CAPSULAR TAB FROM THE RIGHT LOBE NECK WAS FOUND INSIDE THE BLADDER. THE PATIENT HAD URETHRAL STENOSIS SO A STANDARD RIGID ENDOSCOPE COULD NOT BE PASSED THROUGH THE URETHRA. THE WAS MILD FOREIGN BODY FORMATION ON THE CAPSULAR TAB. THEREFORE, THE DOCTOR DECIDED TO OBSERVE THE PROGRESS WITHOUT REMOVING THE IMPLANT. THE PATIENT HAD THE SECOND UROLIFT PROCEDURE ON (B)(6) 2024, BUT HIS URINARY RETENTION WAS NOT RESOLVED. A FLEXIBLE ENDOSCOPY WAS PERFORMED ON (B)(6) 2025, HIS URINARY RETENTION WAS NOT RESOLVED, AND IT WAS FOUND THAT STONES ARE ATTACHED TO THE CAPSULAR TAB. THEREFORE, THE IMPLANTS ARE SCHEDULED TO BE REMOVED IN (B)(6) 2025". THE PATIENTS CURRENT CONDITION IS REPORTED AS "UNKNOWN".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1498851 UROLIFT 2 IMPLANT CARTRIDGE IMPLANTABLE TRANSPROSTATIC TIS PEW NEOTRACT, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown