BEUDAMED
    FDA Adverse Event Death Summary report: N

    NEOTRACT UROLIFT SYSTEM UL400

    MDR report key: 8694067 · Received June 12, 2019

    Report

    Report Number
    3005791775-2019-00018
    Event Type
    Death
    Date Received
    June 12, 2019
    Date of Event
    May 14, 2019
    Report Date
    June 14, 2019
    Manufacturer
    NEOTRACT, INC.
    Product Code
    PEW
    UDI-DI
    00814932020001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ADDED THE PATIENT'S AGE UNIT (YEARS) IN SECTION AS IT WAS MISSED IN THE INITIAL REPORT.

    Description of Event or Problem · 1

    ON (B)(6) 2019, NEOTRACT WAS INFORMED THAT A (B)(6) YEAR OLD PATIENT HAD AN UNEVENTFUL PROSTATIC URETHRAL LIFT (PUL) PROCEDURE ON (B)(6) 2019. THE PATIENT WAS RECATHETERIZED AND SENT HOME. IT WAS REPORTED THAT THE EVENING FOLLOWING THE PROCEDURE, THE PATIENT EXPERIENCED SOME BLEEDING FOR A FEW HOURS BUT WAS REPORTED TO BE OK OVERNIGHT. THE NEXT DAY, IT WAS REPORTED THAT THE PATIENT COLLAPSED WHILE TAKING A SHOWER AND EXPIRED. NO ADDITIONAL INFORMATION WAS RECEIVED DESPITE SEVERAL CONTACT ATTEMPTS WITH THE PHYSICIAN. DUE TO LACK OF INFORMATION, NEOTRACT IS UNABLE TO ASSESS THE RELATIONSHIP OF THE REPORTED DEATH TO THE DEVICE OR PROCEDURE. THE PATIENT WAS IN URINARY RETENTION WITH RECURRING URINARY TRACT INFECTIONS, SEPSIS AND WAS ON ANTIBIOTICS PRIOR TO PUL PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    487735 NEOTRACT UROLIFT SYSTEM UL400 UROLIFT SYSTEM PEW NEOTRACT, INC. UL400 UNKNOWN 00814932020001

    Patients

    Seq Age Sex Outcome Treatment
    1 97 YR Death