BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEOTRACT UROLIFT SYSTEM

    MDR report key: 12694297 · Received October 25, 2021

    Report

    Report Number
    3015181082-2021-00033
    Event Type
    Malfunction
    Date Received
    October 25, 2021
    Date of Event
    September 21, 2021
    Report Date
    October 25, 2021
    Manufacturer
    NEOTRACT, INC.
    Product Code
    PEW
    UDI-DI
    00814932020001
    PMA / PMN Number
    K193269
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 0

    ON (B)(6) 2021, NEOTRACT WAS MADE AWARE OF A PATIENT THAT RECEIVED A SUCCESSFUL PROSTATIC URETHRAL LIFT (PUL). ON 30 SEPT 2021, IT WAS ADDITIONALLY REPORTED THAT DURING THE PROCEDURE, AN UNSPECIFIED LENGTH OF NEEDLE FROM THE DELIVERY DEVICE BROKE OFF DURING THE IMPLANT DEPLOYMENT. THE PHYSICIAN REMOVED THE ENTIRE LENGTH OF THE NEEDLE FRAGMENT FROM THE PATIENT¿S BLADDER AND CONTINUED THE PROCEDURE. NO PATIENT HARM OR ADVERSE EVENTS WERE REPORTED WITH THE RETRIEVAL OR PROCEDURE, AND THE PROCEDURE WAS COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1588293 NEOTRACT UROLIFT SYSTEM UROLIFT SYSTEM PEW NEOTRACT, INC. UROLIFT SYSTEM UNKNOWN 00814932020001

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention