BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEOTRACT UROLIFT SYSTEM UL400

    MDR report key: 8743732 · Received June 28, 2019

    Report

    Report Number
    3005791775-2019-00021
    Event Type
    Injury
    Date Received
    June 28, 2019
    Date of Event
    May 9, 2019
    Report Date
    June 27, 2019
    Manufacturer
    NEOTRACT, INC.
    Product Code
    PEW
    UDI-DI
    00814932020001
    PMA / PMN Number
    K173087
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    ON (B)(4) 2019, NEOTRACT INC. WAS CONTACTED BY A PATIENT WHO HAD RECEIVED A SUCCESSFUL PROSTATIC URETHRAL LIFT (PUL) PROCEDURE ON (B)(6) 2019, AND WAS SENT HOME WITH A CATHETER. SEVERAL DAYS LATER, HIS PHYSICIAN PERFORMED AN URINALYSIS CONFIRMING A UTI WHICH REQUIRED HOSPITALIZATION AND IV ANTIBIOTICS. DURING HOSPITALIZATION, THE PATIENT HAD A TURP PROCEDURE PERFORMED, BUT NO FURTHER INTERVENTIONS WERE REQUIRED. PATIENT WAS HOSPITALIZED FOR A TOTAL OF EIGHT (8) DAYS AND WAS DISCHARGED WHILE STILL RECEIVING IV ANTIBIOTICS WHICH WERE SCHEDULED TO BE DISCONTINUED ON (B)(6) 2019.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    538837 NEOTRACT UROLIFT SYSTEM UL400 UROLIFT SYSTEM PEW NEOTRACT, INC. UL400 UNKNOWN 00814932020001

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Hospitalization| R