BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEOTRACT UROLIFT SYSTEM

    MDR report key: 12801162 · Received November 11, 2021

    Report

    Report Number
    3015181082-2021-00037
    Event Type
    Malfunction
    Date Received
    November 11, 2021
    Date of Event
    September 7, 2021
    Report Date
    November 11, 2021
    Manufacturer
    NEOTRACT, INC.
    Product Code
    PEW
    UDI-DI
    00814932020087
    PMA / PMN Number
    K193269
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    ON 14 SEPT 2021, NEOTRACT WAS MADE AWARE OF A PATIENT THAT RECEIVED A SUCCESSFUL PROSTATIC URETHRAL LIFT (PUL) ON (B)(6) 2021. DURING THE PROCEDURE, IT WAS NOTED THAT ONE IMPLANT DID NOT SUCCESSFULLY DEPLOY. ON (B)(6) 2021, DURING THE DEVICE INVESTIGATION IT WAS NOTED THAT APPROXIMATELY 32MM OF THE NEEDLE TIP WAS RETURNED WITH THE DEVICE BUT HAD BECOME DISCONNECTED FROM THE DEVICE. NO PORTION OF THE NEEDLE WAS UNACCOUNTED FOR. IT WAS REPORTED THAT THE PATIENT WAS DOING FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1698444 NEOTRACT UROLIFT SYSTEM UROLIFT SYSTEM PEW NEOTRACT, INC. UROLIFT SYSTEM P44500 00814932020087

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention