BEUDAMED
    FDA Adverse Event Death Summary report: N

    NEOTRACT UROLIFT SYSTEM UL400

    MDR report key: 8372393 · Received February 26, 2019

    Report

    Report Number
    3005791775-2019-00013
    Event Type
    Death
    Date Received
    February 26, 2019
    Date of Event
    January 24, 2019
    Report Date
    February 26, 2019
    Manufacturer
    NEOTRACT, INC.
    Product Code
    PEW
    UDI-DI
    00814932020001
    PMA / PMN Number
    K173087
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE SINGLE-USE DEVICE (IMPLANT) WAS DEPLOYED UNDER NORMAL CONDITIONS. THE PHYSICIAN STATED HE DOES NOT BELIEVE THE PROCEDURE CONTRIBUTED TO THE PATIENT'S DEATH; HOWEVER, NEOTRACT IS SUBMITTING MDR OUT OF AN ABUNDANCE OF CAUTION.

    Description of Event or Problem · 1

    ON (B)(4) 2019, NEOTRACT WAS INFORMED OF AN (B)(6) PATIENT THAT UNDERWENT PROSTATIC URETHRAL LIFT (PUL) PROCEDURE WITHOUT COMPLICATIONS ON (B)(6) 2019. THE PATIENT HAD SOME DIFFICULTY URINATING POST PROCEDURE; HOWEVER, HE WAS ABLE TO URINATE PRIOR TO RELEASE. THE PATIENT WAS SENT HOME WITHOUT A CATHETER. ON (B)(6) 2019, THE PATIENT EXPIRED AT HOME. OFFICIAL CAUSE OF DEATH FROM DEATH CERTIFICATE WAS NOT PROVIDED AND THE FAMILY DECLINED AN AUTOPSY. THE PHYSICIAN STATED HE DOES NOT BELIEVE THE PROCEDURE CONTRIBUTED TO THE PATIENT'S DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    164361 NEOTRACT UROLIFT SYSTEM UL400 UROLIFT SYSTEM PEW NEOTRACT, INC. UROLIFT SYSTEM UNKNOWN 00814932020001

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Death