BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEOTRACT UROLIFT SYSTEM UL400

    MDR report key: 8875632 · Received August 8, 2019

    Report

    Report Number
    3005791775-2019-00027
    Event Type
    Injury
    Date Received
    August 8, 2019
    Date of Event
    June 7, 2019
    Report Date
    August 8, 2019
    Manufacturer
    NEOTRACT, INC.
    Product Code
    PEW
    PMA / PMN Number
    K173087
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    ON 11 JUNE 2019, NEOTRACT WAS INFORMED OF A PATIENT WITH A SIGNIFICANT PAST MEDICAL HISTORY OF LIVER CIRRHOSIS, ESOPHAGEAL VARICES, CHRONIC VENOUS STASIS, AND BPH WHO RECEIVED A SUCCESSFUL PROSTATIC URETHRAL LIFT (PUL) WITH THE UROLIFT SYSTEM ON (B)(6) 2019. THE PROCEDURE WAS DESCRIBED TO BE UNEVENTFUL AND NO COMPLICATIONS WERE REPORTED. POST PROCEDURE, THE PATIENT WAS DISCHARGED WITH A CATHETER DUE TO SLIGHT BLEEDING. ON (B)(6) 2019, ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE ER ON (B)(6) 2019 AND WAS ADMITTED FOR HEMATURIA, CLOT RETENTION, AND URINARY RETENTION. HE WAS GIVEN AN ORAL ANTIBIOTIC COURSE OF KEFLEX FOR THE TREATMENT OF UTI AND CONTINUOUS BLADDER IRRIGATION (CBI) FOR THREE DAYS. ON (B)(6) 2019, HE UNDERWENT A LIMITED TRANSURETHRAL VAPORIZATION OF ANTERIOR PROSTATE TISSUE WITH FULGURATION OF THE BLADDER NECK. ON (B)(6) 2019, THE HEMATURIA RESOLVED AND HE WAS DISCHARGED FROM THE HOSPITAL. ON (B)(6) 2019, THE PATIENT WAS SEEN FOR FOLLOW UP IN WHICH HE PASSED A VOIDING TRIAL AND REPORTED TO BE DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    669137 NEOTRACT UROLIFT SYSTEM UL400 UROLIFT SYSTEM PEW NEOTRACT, INC. UROLIFT SYSTEM UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Hospitalization