BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UROLIFT

    MDR report key: 12665049 · Received October 19, 2021

    Report

    Report Number
    MW5104768
    Event Type
    Injury
    Date Received
    October 19, 2021
    Date of Event
    October 8, 2021
    Report Date
    October 15, 2021
    Manufacturer
    NEOTRACT, INC.
    Product Code
    PEW
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    AFTER A UROLIFT PROCEDURE WAS PERFORMED ON AN OUTPATIENT BASIS, I EXPERIENCED SERIOUS BLEEDING AND INABILITY TO URINATE 3 DAYS POST PROCEDURE. I WAS HOSPITALIZED WITH DIAGNOSES OF HEMATURIA, ACUTE HYPONATREMIA AND HYPOKALEMIA. DISCHARGED FROM THE HOSPITAL ON (B)(6) 2021 WITH A FOLEY CATHETER WITH INSTRUCTIONS TO REPORT TO UROLOGIST ON MONDAY FOR FOLEY REMOVAL. FOLEY SUCCESSFULLY REMOVED ON (B)(6) 2021. SIGNIFICANT BLEEDING (BLOOD IN URINE) OCCURRED ON (B)(6) 2021 ALONG WITH SIGNIFICANT PAIN ON URINATION AND DIFFICULTY IN URINATION. WENT TO ER AND WAS DIAGNOSED WITH URINARY RETENTION, INFECTION OR INFLAMMATION OF BLADDER URINARY TRACT INFECTION AND DISCHARGED WITH CIPROFLOXACIN HCL 500 MG (1 TABLET BY MOUTH 2X DAILY). FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1559985 UROLIFT IMPLANTABLE TRANSPROSTATIC TISSUE RETRACTOR SYSTEM PEW NEOTRACT, INC. 73F2100537

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Hospitalization