BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BULKAMID

    MDR report key: 24716450 · Received March 30, 2026

    Report

    Report Number
    2124215-2026-17015
    Event Type
    Injury
    Date Received
    March 30, 2026
    Date of Event
    September 1, 2025
    Report Date
    March 27, 2026
    Manufacturer
    CONTURA INTERNATIONAL A/S
    Product Code
    LNM
    PMA / PMN Number
    P170023
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK H11: THIS PRODUCT IS NOT APPROVED IN THE UNITED STATES; HOWEVER, IT HAS BEEN ASSESSED AS REPORTABLE AS THERE IS A SIMILAR PRODUCT APPROVED IN THE UNITED STATES. WE ARE UNABLE TO PROVIDE THE UNIQUE IDENTIFIER (UDI) # AND OTHER SPECIFIC PRODUCT INFORMATION RELATED TO UNITED STATES REGISTRATION AS THE SPECIFIC PRODUCT IS ONLY COMMERCIALLY AVAILABLE OUTSIDE OF THE UNITED STATES.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT WHO UNDERWENT AN INTRAURETHRAL INJECTION OF BULKAMID EXPERIENCED A PERSISTENT SENSATION OF VAGINAL PRESSURE AND HEAVINESS, ASSOCIATED WITH EPISODES OF URETHRAL BLEEDING WITHOUT AN IDENTIFIABLE CAUSE, DESCRIBED BY THE PATIENT AS A SENSATION SIMILAR TO LABOR CONTRACTIONS. IN THE IMMEDIATE POSTOPERATIVE PERIOD, URINARY TRACT INFECTIONS WERE RULED OUT. THE PATIENT REPORTED NO VOIDING SYMPTOMS, AND A CYSTOSCOPY WAS PERFORMED, WHICH SHOWED NORMAL FINDINGS, WITH NO PATHOLOGICAL ABNORMALITIES. DESPITE THIS, THE SYMPTOMS PERSISTED WITHOUT IMPROVEMENT. SUBSEQUENTLY, THE PATIENT DEVELOPED RECURRENT URINARY TRACT INFECTIONS, EVENTUALLY PROGRESSING TO PYELONEPHRITIS. A MAGNETIC RESONANCE IMAGING (MRI) STUDY WAS PERFORMED, REPORTING THAT THE INTRAURETHRAL ADMINISTRATION OF THE SUBSTANCE WAS WITHIN NORMAL LIMITS, WITH NO EVIDENCE OF COMPLICATIONS RELATED TO THE PRODUCT OR THE PROCEDURE. DUE TO THE PERSISTENCE OF SYMPTOMS, A POSSIBLE INFLAMMATORY REACTION WAS SUSPECTED, AND THE PATIENT WAS TREATED WITH SYSTEMIC CORTICOSTEROIDS FOR ONE WEEK, WITH MINIMAL CLINICAL IMPROVEMENT. THE PATIENT REPORTS EXPERIENCING INTERMITTENT DAYS OF SLIGHT IMPROVEMENT, BUT NO RESOLUTION OF SYMPTOMS. ACCORDING TO THE TREATING PHYSICIAN, DUE TO THIS CLINICAL SITUATION, THIS EVENT HAD AFFECTED THE PATIENT'S DAILY LIFE AND REQUIRED TO BE ON SICK LEAVE FOR APPROXIMATELY ONE MONTH. FOLLOWING TREATMENT WITH CORTICOSTEROIDS AND INTRAURETHRAL ADOLONTA, THE PATIENT WAS ABLE TO RETURN TO WORK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    781330 BULKAMID AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE LNM CONTURA INTERNATIONAL A/S 50012 24F2101AA

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Female Disability| R