BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEOTRACT UROLIFT SYSTEM

    MDR report key: 12602235 · Received October 9, 2021

    Report

    Report Number
    3015181082-2021-00031
    Event Type
    Injury
    Date Received
    October 9, 2021
    Date of Event
    September 9, 2021
    Report Date
    October 8, 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
    PHYSICIAN

    Narratives

    Description of Event or Problem · 0

    ON 9 SEPT 2021, NEOTRACT WAS MADE AWARE OF A PATIENT THAT DEVELOPED AN INFECTION AFTER A SUCCESSFULLY COMPLETED PROSTATIC URETHRAL LIFT (PUL) PROCEDURE ON (B)(6) 2021. PRIOR TO PUL, THE PATIENT DID NOT HAVE A URINALYSIS PERFORMED, BUT WAS PRESCRIBED CIPROFLOXACIN AS A PROPHYLACTIC PRE-PROCEDURAL ANTIBIOTIC. POST PROCEDURE, HE WAS PRESCRIBED LEVAQUIN FOR FIVE DAYS. AT AN UNDETERMINED TIME LATER, THE PATIENT PRESENTED TO THE ER WITH A UTI (CULTURING STRAIN OF KLEBSIELLA PNEUMONIAE). A URINE CULTURE WAS PERFORMED INDICATING THE UTI WAS RESISTANT TO CIPROFLOXACIN AND LEVAQUIN, AND THE PATIENT SUBSEQUENTLY DEVELOPED SEPSIS. HE WAS ADMITTED TO THE HOSPITAL FOR FOUR DAYS AS HE RECEIVED IV ANTIBIOTICS. HE WAS REPORTED TO BE DOING WELL. THE UROLOGIST PERFORMED FOUR (4) PUL PROCEDURES ON (B)(6) 2021 AND ALL PATIENTS DEVELOPED INFECTIONS. IT IS NOT SUSPECTED THAT THE INFECTION WAS CAUSED BY THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1499734 NEOTRACT UROLIFT SYSTEM UROLIFT SYSTEM PEW NEOTRACT, INC. UROLIFT SYSTEM UNKNOWN 00814932020001

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R