BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEOTRACT UROLIFT SYSTEM UL400

    MDR report key: 4890724 · Received July 1, 2015

    Report

    Report Number
    3005791775-2015-00005
    Event Type
    Injury
    Date Received
    July 1, 2015
    Date of Event
    May 27, 2015
    Report Date
    July 1, 2015
    Manufacturer
    NEOTRACT, INC.
    Product Code
    PEW
    PMA / PMN Number
    K133281
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ON (B)(6) 2015, THE COMPANY BECAME AWARE THAT PATIENT ON ANTICOAGULATION FOR A HEART VALVE WITH A HISTORY OF MULTIPLE TRANSFUSION-REQUIRING BLEEDING EPISODES UNDERWENT AN UNEVENTFUL UROLIFT SYSTEM TREATMENT ON (B)(6) 2015. THE PATIENT DISCONTINUED WARFARIN AND WAS ANTICOAGULATED WITH LOVENOX THROUGH THE TIME OF THE PROCEDURE. HE WAS RESTARTED ON WARFARIN AFTER THE PROCEDURE. NINE DAYS AFTER HIS PROCEDURE AND DURING HIS SECOND SEXUAL ENCOUNTER POST IMPLANTATION, THE PATIENT DEVELOPED A RETROPERITONEAL HEMORRHAGE. THE PATIENT WAS ADMITTED TO THE HOSPITAL, RECEIVED BLOOD TRANSFUSIONS AND WAS OBSERVED UNDER CONSERVATIVE CARE. HE WAS DISCHARGED IN STABLE CONDITION 1 WEEK LATER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    426311 NEOTRACT UROLIFT SYSTEM UL400 UROLIFT SYSTEM PEW NEOTRACT, INC. UL400 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Hospitalization