BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BULKAMID

    MDR report key: 14288441 · Received May 4, 2022

    Report

    Report Number
    MW5109525
    Event Type
    Injury
    Date Received
    May 4, 2022
    Date of Event
    January 17, 2022
    Report Date
    May 2, 2022
    Manufacturer
    CONTURA INTERNATIONAL A/S
    Product Code
    LNM
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MN, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    I WAS TREATED WITH BULKAMID FOR URINARY LEAKAGE IN (B)(6) 2021. AFTER THE PROCEDURE, I DID HAVE ANY ISSUES UNTIL ABOUT 1 MO LATER AND THEN I STARTED TO GET UTIS. I WAS TREATED WITH ANTIBIOTICS. NOW IN APRIL I CAN'T EMPTY MY BLADDER ALL THE WAY AND HAVE TO URINATE ALL THE TIME. IF I GET UP TO WALK, I HAVE TO GO TO THE BATHROOM EVERY TIME. IT ALSO BURNS WHEN I PEE ALTHOUGH I DON'T HAVE AN UTI. I BELIEVE THE PROCEDURE HAS CREATED NEW ISSUES BESIDE LEAKAGE. I DON'T KNOW IF THEY PUT TOO MUCH IN, WHETHER MY BODY IS SENSITIVE TO THE MATERIAL OR WHETHER MY PROLAPSE HAS WORSEN. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1565591 BULKAMID AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE LNM CONTURA INTERNATIONAL A/S

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Female