BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UROLIFT IMPLANTS

    MDR report key: 11848077 · Received May 18, 2021

    Report

    Report Number
    MW5101419
    Event Type
    Malfunction
    Date Received
    May 18, 2021
    Date of Event
    February 8, 2021
    Report Date
    May 7, 2021
    Manufacturer
    NEOTRACT, INC.
    Product Code
    PEW
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    AZ, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    HAD UROLIFT PROCEDURE IN FEBRUARY. UROLOGIST HAS TOLD ME IMPLANTS FAILED AND ARE NO LONGER IN PLACE. FOUR (4) OF FIVE (5) UROLIFT IMPLANT DEVICES COULD NOT BE FOUND IN MY BODY AT THIS POINT IN TIME BY MY UROLOGIST. TWO WEEKS AFTER THE PROCEDURE, I KNEW SOMETHING WAS WRONG. LT WASN'T UNTIL A CYSTOSCOPY (REQUESTED BY ME) ON MAY 4TH THAT MY SURGEON SAID 4 OF 5 IMPLANTS ARE GONE. MY UROLOGIST WAS AMAZED AND SAID HE "HAS NEVER SEEN ANYTHING LIKE THIS BEFORE". MY FEAR NOW IS THAT THE FAILED IMPLANT MATERIAL MAY STILL BE SOMEWHERE IN MY BODY. UROLIFT PROCEDURES ARE BEING PERFORMED ON THOUSANDS OF MEN ACROSS AMERICA. I ALSO WORRY THAT MY EVENT COULD HAPPEN TO MANY MORE MEN. ULTRASOUND WAS THE TEST THAT SHOWED 4 OF 5 IMPLANTS MISSING. I AM NOW FACED WITH TRYING TO FIGURE OUT WHAT TO DO NEXT. WILL THE FAILED IMPLANT MATERIAL STAY IN MY BODY SOMEWHERE AND HURT ME IN THE FUTURE? WHAT TYPE OF PROCEDURE SHOULD I TRY NEXT TO ALLEVIATE MY ORIGINAL MEDICAL CONDITION? WILL NEW PROCEDURE BE COMPATIBLE WITH THE FAILED IMPLANT MATERIAL?

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    737980 UROLIFT IMPLANTS IMPLANTABLE TRANSPROSTATIC TISSUE RETRACTOR SYSTEM PEW NEOTRACT, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Other