BEUDAMED
    FDA Adverse Event Death Summary report: N

    NEOTRACT UROLIFT SYSTEM

    MDR report key: 9729662 · Received February 19, 2020

    Report

    Report Number
    3005791775-2020-00009
    Event Type
    Death
    Date Received
    February 19, 2020
    Date of Event
    January 18, 2020
    Report Date
    February 19, 2020
    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

    Description of Event or Problem · 1

    ON 21 JAN 2020, NEOTRACT WAS NOTIFIED OF A PATIENT WHO UNDERWENT A SUCCESSFUL PROSTATIC URETHRAL LIFT (PUL) PROCEDURE ON (B)(6) 2020. THE PROCEDURE WAS DESCRIBED TO BE UNEVENTFUL AND NO COMPLICATIONS WERE REPORTED. ON THE MORNING OF (B)(6) 2020, THE HOME HEALTHCARE NURSE FOUND THE PATIENT LYING ON THE BATHROOM FLOOR. LATER THAT DAY, THE PHYSICIAN REPORTED THAT HE WAS NOTIFIED THE PATIENT CODED AT HOME AND EXPIRED. THE PHYSICIAN STATED THAT HE DOES NOT BELIEVE THE PATIENT DEATH WAS RELATED TO THE PUL PROCEDURE, AND DECLINED TO PROVIDE ANY ADDITIONAL INFORMATION. ON 30 JAN 2020, DURING FOLLOW UP CALL, THE PHYSICIAN DECLINED TO PROVIDE ANY FURTHER DETAILS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    192223 NEOTRACT UROLIFT SYSTEM UROLIFT SYSTEM PEW NEOTRACT, INC. UL400 UNKNOWN 00814932020001

    Patients

    Seq Age Sex Outcome Treatment
    1 Death