BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEOTRACT UROLIFT SYSTEM

    MDR report key: 11785716 · Received May 6, 2021

    Report

    Report Number
    3015181082-2021-00013
    Event Type
    Injury
    Date Received
    May 6, 2021
    Date of Event
    March 4, 2021
    Report Date
    May 6, 2021
    Manufacturer
    NEOTRACT, INC.
    Product Code
    PEW
    UDI-DI
    00814932020001
    PMA / PMN Number
    K193269
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    ON (B)(4) 2021, NEOTRACT WAS MADE AWARE OF A PATIENT THAT UNDERWENT A SUCCESSFUL PROSTATIC URETHRAL LIFT (PUL) PROCEDURE ON (B)(6) 2020. ON (B)(6) 2021, IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE PHYSICIAN ON (B)(6) 2021 EXPERIENCING DYSURIA, NOCTURIA, HEMATURIA, INFECTION, RETENTION, AND BLEEDING. ON (B)(6) 2021, IT WAS REPORTED THAT THE PATIENT UNDERWENT A PROCEDURE TO REMOVE A DISLODGED IMPLANT THAT CREATED GRANULOMAS AND A TUR-B PROCEDURE. THE PATIENT WAS REPORTED AS DOING WELL AND URINATING WITHOUT PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    681488 NEOTRACT UROLIFT SYSTEM UROLIFT SYSTEM PEW NEOTRACT, INC. UROLIFT SYSTEM UNKNOWN 00814932020001

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention