BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UROLIFT

    MDR report key: 19392784 · Received May 23, 2024

    Report

    Report Number
    MW5155362
    Event Type
    Injury
    Date Received
    May 23, 2024
    Date of Event
    July 19, 2022
    Report Date
    May 22, 2024
    Manufacturer
    TELEFLEX, INC. / TELEFLEX LLC (NADC)
    Product Code
    PEW
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CO, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    (B)(6) 2022 ¿ IMPLANTATION OF 2 UROLIFT PROSTATE RETRACTION DEVICES. BLEEDING WAS EXPECTED TO LAST 2-4 WEEKS HOWEVER, URINARY AND SEMINAL BLOOD CONTINUED ROUTINELY FOR APPROXIMATELY 16 MONTHS. AFTER A BRIEF REPRIEVE IT IS ALMOST 2 YEARS POST-IMPLANTATION AND BLEEDING HAS RESUMED. FOLLOW-UP IMAGING AND A SECOND OPINION REVEAL NO CLEAR CAUSE OR REMEDY. THE BLEEDING IS WORSE WITH PHYSICAL ACTIVITY. SOME DISCOMFORT HAS PERSISTED BUT IS WORSE WHEN BLOOD IS EVIDENT. LAB RESULTS AND IMAGES WERE REVIEWED BY 2ND PHYSICIAN ON (B)(6) 2023, NOTHING DETERMINED. "22089430".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1938991 UROLIFT IMPLANTABLE TRANSPROSTATIC TISSUE RETRACTOR SYSTEM PEW TELEFLEX, INC. / TELEFLEX LLC (NADC) UL2-H P01012

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Male