BEUDAMED
    FDA Adverse Event Death Summary report: N

    NEOTRACT UROLIFT SYSTEM UL400

    MDR report key: 10551386 · Received September 17, 2020

    Report

    Report Number
    3005791775-2020-00042
    Event Type
    Death
    Date Received
    September 17, 2020
    Date of Event
    August 18, 2020
    Report Date
    September 17, 2020
    Manufacturer
    NEOTRACT, INC.
    Product Code
    PEW
    UDI-DI
    00814932020001
    PMA / PMN Number
    K193269
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2020, NEOTRACT WAS NOTIFIED OF A (B)(6) YEAR OLD PATIENT THAT UNDERWENT A SUCCESSFULLY COMPLETED PROSTATIC URETHRAL LIFT (PUL) PROCEDURE. THE PATIENT WAS NOT ON ANTICOAGULANT THERAPY AND ASPIRIN WAS HELD SIX DAYS PRIOR TO THE PUL PROCEDURE. POST PROCEDURE, THE PATIENT WAS BECAME HYPOTENSIVE WITH A DISTENDED ABDOMEN AND RETROPERITONEAL BLEED. HE EXPERIENCED A DOWNWARD TREND IN HEMOGLOBIN LEVELS AND REQUIRED MULTIPLE TRANSFUSIONS AND EMBOLIZATION. THE PATIENT CONTINUED TO DECLINE AND EXPIRED ON (B)(6) 2020.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1010546 NEOTRACT UROLIFT SYSTEM UL400 UROLIFT SYSTEM PEW NEOTRACT, INC. UL400 UNKNOWN 00814932020001

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Death