BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEOTRACT UROLIFT SYSTEM

    MDR report key: 11661609 · Received April 13, 2021

    Report

    Report Number
    3015181082-2021-00011
    Event Type
    Injury
    Date Received
    April 13, 2021
    Date of Event
    March 5, 2021
    Report Date
    April 13, 2021
    Manufacturer
    NEOTRACT, INC.
    Product Code
    PEW
    UDI-DI
    00814932020001
    PMA / PMN Number
    K193269
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 1

    ON 10 MARCH 2021, NEOTRACT WAS MADE AWARE OF A PATIENT THAT UNDERWENT A SUCCESSFUL PROSTATIC URETHRAL LIFT (PUL) PROCEDURE ON (B)(6) 2021. DURING AND AFTER THE PROCEDURE, IT WAS REPORTED THAT THE PATIENT EXPERIENCED BLEEDING WHICH REQUIRED A CATHETER AND HOSPITAL ADMISSION. ON 18 MARCH 2021, NEOTRACT WAS MADE AWARE THAT HE UNDERWENT SEVERAL ASPIRATIONS AND RECEIVED BLOOD TRANSFUSION. ON (B)(6) 2021, HE WAS DISCHARGED AND HE IS REPORTED TO BE DOING WELL AND SATISFIED WITH HIS IMPROVED URINARY FLOW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    558944 NEOTRACT UROLIFT SYSTEM UROLIFT SYSTEM PEW NEOTRACT, INC. UROLIFT SYSTEM UNKNOWN 00814932020001

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R