BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEOTRACT UROLIFT SYSTEM UL400

    MDR report key: 4548793 · Received February 24, 2015

    Report

    Report Number
    3005791775-2015-00001
    Event Type
    Injury
    Date Received
    February 24, 2015
    Date of Event
    January 20, 2015
    Report Date
    February 14, 2015
    Manufacturer
    NEOTRACT, INC.
    Product Code
    PEW
    PMA / PMN Number
    K133281
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    BLEEDING EVENTS ARE NOT AN UNEXPECTED CONSEQUENCE OF UROLOGICAL PROCEDURES INVOLVING NEEDLE DEPLOYMENTS IN THE PROSTATE. OF NOTE, SIGNIFICANT BLEEDING HAS BEEN REPORTED IN UP TO 1% OF PTS RECEIVING NEEDLE BIOPSY OF THE PROSTATE (REFERENCE: BRULLET ET AL. "MASSIVE RECTAL BLEEDING FOLLOWING TRANSRECTAL ULTRASOUND-GUIDED PROSTATE BIOPSY", ENDOSCOPY 2000; 32 (10):792-5.)

    Description of Event or Problem · 1

    ON (B)(4) 2015 NEOTRACT BECAME AWARE OF AN INCIDENT WITH A PT THAT REC'D FOUR UROLIFT IMPLANTS AS PART OF A UROLIFT PROCEDURE ON (B)(6), 2015. THE PROCEDURE WAS CONDUCTED IN A NORMAL FASHION, WITHOUT INTRAOPERATIVE COMPLICATION OR EVENT. THERE WERE NO ISSUES WITH THE DEVICES AND THEY PERFORMED IN ACCORDANCE WITH THEIR SPEC THEREFORE THE PHYSICIAN DISPOSED OF THE DELIVERY SYSTEMS AT THE CONCLUSION OF THE PROCEDURE. APPROXIMATELY 6-7 HOURS AFTER DISCHARGE, THE PT RETURNED FOR EVAL OF SEVERE ABDOMINAL PAIN. ACCORDING TO THE PHYSICIAN, A CT SCAN WAS ORDERED WHICH DEMONSTRATED A LARGE AMOUNT OF HEMORRHAGE AND STRANDING WITHIN THE LEFT RETROPERITONEUM AND SPACE RETZIUS. IV FLUID SUPPORT WAS GIVEN TO THE PT WHILE IN THE HOSP. THE PT WAS DISCHARGED 3 DAYS LATER IN STABLE CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    129200 NEOTRACT UROLIFT SYSTEM UL400 UROLIFT SYSTEM PEW NEOTRACT, INC. UL400 P13522

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Hospitalization