BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UROLIFT IMPLANT

    MDR report key: 11885317 · Received May 25, 2021

    Report

    Report Number
    MW5101547
    Event Type
    Injury
    Date Received
    May 25, 2021
    Date of Event
    March 23, 2021
    Report Date
    May 17, 2021
    Manufacturer
    NEOTRACT INC.
    Product Code
    PEW
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    CONSTANT INFECTIONS THE LAST ONE, RESISTANT, TO ORAL MEDICATION. I HAD A UROLIFT DEVICE PLACED IN MY PROSTATE, ON (B)(6) 2018, WHICH LEFT ME WITH CONSTANT UTI'S. ON (B)(6) 2020, I HAD A PROCEDURE, CALLED REXUM, WHICH OPENED UP MY URETHRA, BUT STILL HAD THE INFECTIONS. AFTER CHECKING, WITH A SCOPE, THE UROLIFT DEVICE, WAS NOW EXPOSED AND HAD CALCIUM DEPOSITS. DR. (B)(6), THEN DECIDED, THAT THE UROLIFT DEVICE HAD TO BE REMOVED, WHICH RESULTED IN AN INFECTION, RESISTANT TO ORAL MEDICATION; STILL DEALING WITH PAIN BUT MOST UNCOMFORTABLE "IM NOW INCONTINENT, HAVING TO WEAR DEPENDS".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    772847 UROLIFT IMPLANT IMPLANTABLE TRANSPROSTATIC TISSUE RETRACTOR SYSTEM PEW NEOTRACT INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Hospitalization| O| R