BEUDAMED
    FDA Adverse Event Death Summary report: N

    NEOTRACT UROLIFT SYSTEM UL400

    MDR report key: 8919020 · Received August 21, 2019

    Report

    Report Number
    3005791775-2019-00028
    Event Type
    Death
    Date Received
    August 21, 2019
    Date of Event
    July 23, 2019
    Report Date
    August 21, 2019
    Manufacturer
    NEOTRACT, INC.
    Product Code
    PEW
    UDI-DI
    00814932020001
    PMA / PMN Number
    K173087
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2019, NEOTRACT WAS INFORMED THAT AN (B)(6)-YEAR OLD PATIENT, DESCRIBED TO BE WHEELCHAIR BOUND DUE TO FRAIL HEALTH, UNDERWENT A SUCCESSFUL PROSTATIC URETHRAL LIFT (PUL) PROCEDURE WITH NO COMPLICATIONS ON (B)(6) 2019. THE REPORT ALSO STATED THAT THE PATIENT WAS FOUND UNRESPONSIVE ONE DAY POST PROCEDURE, WAS TRANSPORTED BY AMBULANCE TO THE HOSPITAL AND INTUBATED. DURING HOSPITALIZATION, A PELVIC HEMATOMA WAS IDENTIFIED. HE WAS TREATED CONSERVATIVELY WITH VASOPRESSORS, TRANSFUSED WITH ONE UNIT OF BLOOD, AND GIVEN IV ANTIBIOTICS FOR PRESUMPTIVE INFECTION. ON (B)(6) 2019, THE PATIENTS FAMILY DECIDED TO WITHDRAW SUPPORTIVE CARE  HE WAS EXTUBATED AND EXPIRED SHORTLY AFTER. OFFICIAL CAUSE OF DEATH IS NOT YET KNOWN. THE PHYSICIAN STATED THAT HE DOES NOT FEEL THE PROCEDURE CONTRIBUTED TO THE PATIENTS DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    708940 NEOTRACT UROLIFT SYSTEM UL400 UROLIFT SYSTEM PEW NEOTRACT, INC. UROLIFT SYSTEM UNKNOWN 00814932020001

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR Death| H| O