BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEOTRACT UROLIFT SYSTEM

    MDR report key: 12046649 · Received June 22, 2021

    Report

    Report Number
    3015181082-2021-00017
    Event Type
    Injury
    Date Received
    June 22, 2021
    Date of Event
    May 25, 2021
    Report Date
    June 22, 2021
    Manufacturer
    NEOTRACT, INC.
    Product Code
    PEW
    UDI-DI
    00814932020001
    PMA / PMN Number
    K193269
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2021, NEOTRACT BECAME AWARE OF A PATIENT WHOSE INFLATABLE PENILE PROSTHESIS (IPP) WOULD NOT INFLATE FOLLOWING A PROSTATIC URETHRAL LIFT (PUL) PROCEDURE. ON (B)(6) 2021, THE PHYSICIAN REMOVED AND REPLACED THE IPP AND NOTED THAT THE UROLIFT IMPLANT SUTURE WAS DEPLOYED INSIDE THE IPP RESERVOIR. THE PATIENT WAS REPORTED TO BE DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    940790 NEOTRACT UROLIFT SYSTEM UROLIFT SYSTEM PEW NEOTRACT, INC. UROLIFT SYSTEM UNKNOWN 00814932020001

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention