BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEOTRACT UROLIFT SYSTEM UL400

    MDR report key: 8701128 · Received June 14, 2019

    Report

    Report Number
    3005791775-2019-00019
    Event Type
    Injury
    Date Received
    June 14, 2019
    Date of Event
    May 16, 2019
    Report Date
    June 14, 2019
    Manufacturer
    NEOTRACT, INC.
    Product Code
    PEW
    UDI-DI
    00814932020001
    PMA / PMN Number
    K173087
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2019 NEOTRACT INC. WAS CONTACTED BY A PATIENT WHO HAD RECEIVED A SUCCESSFUL PROSTATIC URETHRAL LIFT (PUL) PROCEDURE APPROXIMATELY TWO YEARS AGO. PATIENT STATED THAT HE EXPERIENCED PAIN AND ACCUMULATION OF BLOOD IN HIS CATHETER FOLLOWING THE PUL PROCEDURE. HE WENT TO THE ER (DATE NOT SPECIFIED) WITH BLOOD CLOTS IN HIS URINE, AND HIS CATHETER WAS CHANGED TO A LARGER ONE AND HE WAS SENT HOME. PATIENT STATED THAT A SHORT TIME AFTER HIS VISIT, HE RETURNED TO THE HOSPITAL FOR THE SAME ISSUE WHERE HE WAS TREATED WITH CAUTERIZATION FOR AN ACTIVE BLEED AND TRANSFUSION OF TWO UNITS OF WHOLE BLOOD. HE WAS DISCHARGED AFTER TWO DAYS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    492269 NEOTRACT UROLIFT SYSTEM UL400 UROLIFT SYSTEM PEW NEOTRACT, INC. UL400 UNKNOWN 00814932020001

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Hospitalization| R