BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEOTRACT UROLIFT SYSTEM

    MDR report key: 14686551 · Received June 14, 2022

    Report

    Report Number
    3015181082-2022-00009
    Event Type
    Injury
    Date Received
    June 14, 2022
    Date of Event
    May 6, 2022
    Report Date
    June 14, 2022
    Manufacturer
    NEOTRACT, INC
    Product Code
    PEW
    UDI-DI
    00814932020001
    PMA / PMN Number
    K193269
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    ON (B)(6) 2022, NEOTRACT WAS MADE AWARE OF A PATIENT THAT HAD RECEIVED A SUCCESSFUL PROSTATIC URETHRAL LIFT (PUL) PROCEDURE ON (B)(6) 2022. ON (B)(6) 2022, THE PATIENT EXPERIENCED DIZZINESS AND WEAKNESS. ON (B)(6) 2022, HE PRESENTED TO THE HOSPITAL DUE TO ONGOING SYMPTOMS WHERE HE RECEIVED A BLOOD TRANSFUSION OF 2 UNITS DUE TO A HEMATOMA. NO ADDITIONAL INTERVENTIONS OCCURRED, AND THE PATIENT WAS DISCHARGED ON (B)(6) 2022. DURING A FOLLOW UP APPOINTMENT ON (B)(6) 2022, THE PATIENT WAS REPORTED AS DOING FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1788350 NEOTRACT UROLIFT SYSTEM UROLIFT SYSTEM PEW NEOTRACT, INC UROLIFT SYSTEM UNKNOWN 00814932020001

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Hospitalization| R