BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UROLIFT

    MDR report key: 22419908 · Received July 7, 2025

    Report

    Report Number
    MW5172347
    Event Type
    Injury
    Date Received
    July 7, 2025
    Date of Event
    February 1, 2025
    Report Date
    July 3, 2025
    Manufacturer
    TELEFLEX MEDICAL LLC
    Product Code
    PEW
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    GA, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    THE PATIENT REPORTED UNDERGOING A CT SCAN APPROXIMATELY TWO WEEKS AGO ON TUESDAY. DURING THE SCAN, IT WAS FOUND THAT ALL THREE COMPONENTS OF THE UROLIFT DEVICE, WHICH HAD BEEN IMPLANTED APPROXIMATELY FOUR MONTHS EARLIER IN FEBRUARY, WERE NO LONGER PRESENT AND APPEARED TO HAVE BECOME DISLODGED. THE PATIENT STATED THAT A HOLE WAS IDENTIFIED IN THEIR KIDNEY AND EXPRESSED CONCERN THAT THE UROLIFT DEVICE MAY HAVE CAUSED THE DAMAGE. THE PATIENT ALSO REPORTED EXPERIENCING LOWER ABDOMINAL PAIN, BACK PAIN AND HEMATURIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    176417 UROLIFT IMPLANTABLE TRANSPROSTATIC TISSUE RETRACTOR SYSTEM PEW TELEFLEX MEDICAL LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Male