BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEOTRACT UROLIFT SYSTEM UL400

    MDR report key: 9151625 · Received October 3, 2019

    Report

    Report Number
    3005791775-2019-00035
    Event Type
    Injury
    Date Received
    October 3, 2019
    Date of Event
    December 28, 2018
    Report Date
    October 3, 2019
    Manufacturer
    NEOTRACT, INC.
    Product Code
    PEW
    UDI-DI
    00814932020001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ON 3 SEPTEMBER 2019, NEOTRACT WAS NOTIFIED ABOUT A PATIENT, WITH A HISTORY OF NOCTURIA, RECURRENT PROSTATE INFECTIONS, AND ALLERGY TO MULTIPLE ANTIBIOTICS, WHO UNDERWENT A SUCCESSFUL PROSTATIC URETHRAL LIFT (PUL) PROCEDURE WITH THE UROLIFT SYSTEM ON (B)(6) 2018. POST PROCEDURE, THE PATIENT WAS DISCHARGED WITH A CATHETER. A COUPLE OF DAYS LATER, HE EXPERIENCED A FEVER AND RECEIVED ANTIBIOTICS. AFTER SEVERAL TRIALS WITHOUT A CATHETER, HE WAS ADVISED TO SELF CATHETERIZE FOR APPROXIMATELY THREE (3) MONTHS. AT A FOUR (4) MONTH FOLLOW UP APPOINTMENT, A URINE CULTURE WAS POSITIVE FOR BACTERIA. ON (B)(6) 2019, HE WAS ADMITTED TO THE HOSPITAL FOR THREE (3) DAYS AND RECEIVED IV ANTIBIOTICS. AT A FOLLOW UP APPOINTMENT WITH HIS PRIMARY CARE PHYSICIAN, HE WAS INSTRUCTED TO TAKE ANTIBIOTIC SHOTS FOR TEN (10) DAYS. ON (B)(6) 2019, TWO OF THE FIVE IMPLANTS WERE REMOVED. THE PATIENT REPORTED THAT HE NO LONGER SELF CATHETERIZES AND STATED HE FEELS MUCH BETTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    945356 NEOTRACT UROLIFT SYSTEM UL400 UROLIFT SYSTEM PEW NEOTRACT, INC. UL400 UNKNOWN 00814932020001

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R