BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEOTRACT UROLIFT 2 SYSTEM

    MDR report key: 17686783 · Received September 5, 2023

    Report

    Report Number
    3015181082-2023-00035
    Event Type
    Malfunction
    Date Received
    September 5, 2023
    Date of Event
    July 13, 2023
    Report Date
    September 5, 2023
    Manufacturer
    NEOTRACT, INC.
    Product Code
    PEW
    UDI-DI
    10814932020299
    PMA / PMN Number
    K201837
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    ON (B)(6) 2023, NEOTRACT WAS MADE AWARE OF A PATIENT WHO RECEIVED A SUCCESSFUL PROSTATIC URETHRAL LIFT (PUL) PROCEDURE. DURING THE PROCEDURE, THE PHYSICIAN NOTICED THAT THE NEEDLE WAS EXPOSED WHILE OPENING THE IMPLANT PACKAGE. IT WAS REPORTED THAT THE DEVICE WAS NOT USED, AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO PATIENT HARM OR INJURY. INVESTIGATION OF THE RETURNED DEVICE ON (B)(6) 2023 CONFIRMED THAT APPROXIMATELY .86MM OF THE NEEDLE TIP WAS BROKEN AND UNACCOUNTED FOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    987045 NEOTRACT UROLIFT 2 SYSTEM UROLIFT 2 SYSTEM PEW NEOTRACT, INC. UROLIFT 2 SYSTEM P02712 10814932020299

    Patients

    Seq Age Sex Outcome Treatment
    1 Male