BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEOTRACT UROLIFT SYSTEM

    MDR report key: 12000339 · Received June 15, 2021

    Report

    Report Number
    3015181082-2021-00016
    Event Type
    Injury
    Date Received
    June 15, 2021
    Date of Event
    May 14, 2021
    Report Date
    June 15, 2021
    Manufacturer
    NEOTRACT, INC.
    Product Code
    PEW
    UDI-DI
    00814932020001
    PMA / PMN Number
    K193269
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    ON (B)(6), NEOTRACT WAS MADE AWARE OF A (B)(6) YEAR OLD PATIENT WHO UNDERWENT A PROSTATIC URETHRAL LIFT (PUL) PROCEDURE ON (B)(6) 2021. THE PHYSICIAN UTILIZED A BUGBEE TO CONTROL THE BLEEDING. THE PATIENT WAS DISCHARGED WITH A CATHETER. LATER THAT EVENING, THE PATIENT PRESENTED WITH HEMATURIA AND CLOT RETENTION REQUIRING BLADDER IRRIGATION. IT WAS REPORTED THAT THE PATIENT¿S BLOOD CLOTS CAUSED OBSTRUCTION AND INABILITY TO VOID. THE PHYSICIAN PERFORMED A PARTIAL TURP AND DIATHERMY TO STOP THE BLEEDING. THE PATIENT¿S URINE CLEARED BY THE NEXT EVENING AND WAS DISCHARGED WITH A CATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    900980 NEOTRACT UROLIFT SYSTEM UROLIFT SYSTEM PEW NEOTRACT, INC. UROLIFT SYSTEM P44624 00814932020001

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention