BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BULKAMID

    MDR report key: 23764348 · Received December 9, 2025

    Report

    Report Number
    2124215-2025-90014
    Event Type
    Injury
    Date Received
    December 9, 2025
    Date of Event
    October 9, 2025
    Report Date
    December 9, 2025
    Manufacturer
    CONTURA INTERNATIONAL A/S
    Product Code
    LNM
    UDI-DI
    05704101500128
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK H6: PATIENT CODE E172001 IS BEING USED TO CAPTURE THE REPORTABLE EVENT OF ABSCESS. PATIENT CODE E1301IS BEING USED TO CAPTURE THE REPORTABLE EVENT OF DYSURIA. PATIENT CODE E1308 IS BEING USED TO CAPTURE THE REPORTABLE EVENT OF URINARY FREQUENCY. PATIENT CODE E1304 IS BEING USED TO CAPTURE THE REPORTABLE EVENT OF URINARY URGENCY. PATIENT CODE E2338 IS BEING USED TO CAPTURE THE REPORTABLE EVENT OF SWELLING. BLOCK H11: WE ARE UNABLE TO PROVIDE THE UNIQUE IDENTIFIER (UDI) # FOR THIS PRODUCT. ALL AVAILABLE PRODUCT DATA HAS BEEN INCLUDED IN THIS REPORT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT A BULKAMID PROCEDURE ON (B)(6) 2025, UNDER GENERAL ANESTHESIA. PROPHYLACTIC ANTIBIOTICS WERE ADMINISTERED, AND THE PATIENT WAS DISCHARGED WITH A THREE-DAY COURSE OF NITROFURANTOIN. DURING THE FIRST THREE MONTHS POST-PROCEDURE, THE PATIENT REMAINED ASYMPTOMATIC. SUBSEQUENTLY, THEY DEVELOPED INCREASED URINARY FREQUENCY, URGENCY, AND DYSURIA. ON (B)(6)2025, THE PATIENT WAS EVALUATED BY THE TREATING PHYSICIAN. A MID-STREAM URINE SAMPLE WAS OBTAINED AND RETURNED NEGATIVE. VAGINAL EXAMINATION REVEALED A NORMAL URETHRA AND BLADDER NECK. A FOLLOW-UP PHONE CALL ON (B)(6) 2025, CONFIRMED PERSISTENT SYMPTOMS. ON (B)(6) 2025, THE PATIENT PRESENTED TO THE EMERGENCY DEPARTMENT WITH VAGINAL SWELLING. EXAMINATION BY A CONSULTANT PHYSICIAN IDENTIFIED A 4 CM ANTERIOR VAGINAL WALL MASS. LABORATORY RESULTS WERE WITHIN NORMAL LIMITS EXCEPT FOR LEUCOCYTOSIS OF 12. ON (B)(6) 2025, AN URGENT MAGNETIC RESONANCE IMAGING (MRI) SCAN WAS PERFORMED, REVEALING A LOCULATED, APPARENTLY CYSTIC PARAURETHRAL STRUCTURE. ON (B)(6) 2025, THE PATIENT WAS ADMITTED FOR EXAMINATION UNDER ANESTHESIA. ASPIRATION OF THE MASS YIELDED FRANK PUS, PROMPTING A LINEAR ANTERIOR VAGINAL WALL INCISION. A MULTILOCULATED COLLECTION OF PUS SURROUNDING THE URETHRA WAS EVACUATED. A DRAIN WAS PLACED FOR TWO DAYS, AND THE PATIENT WAS DISCHARGED WITH AN INDWELLING URINARY CATHETER FOR TWO WEEKS. ON (B)(6) 2025, THE PATIENT RETURNED FOR OUTPATIENT REVIEW. EXAMINATION SHOWED NO RESIDUAL PARAURETHRAL COLLECTION OR COMPLICATIONS. THE CATHETER WAS REMOVED, AND THE PATIENT VOIDED FREELY. THE PATIENT REMAINED ON CO-AMOXICLAV (AMOXICILLIN/CLAVULANIC ACID) 625 MG THREE TIMES DAILY, WITH A PLANNED FOUR-WEEK ANTIBIOTIC COURSE. MICROBIOLOGICAL CULTURE OF THE DRAINED FLUID DID NOT IDENTIFY A CAUSATIVE ORGANISM. NUCLEIC ACID AMPLIFICATION TEST (NAAT) FOR CHLAMYDIA TRACHOMATIS, NEISSERIA GONORRHOEAE, AND MYCOPLASMA SPECIES WAS NEGATIVE. IN THE PHYSICIAN'S ASSESSMENT, THIS COMPLICATION WAS CONSIDERED RELATED TO THE BULKAMID TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2107936 BULKAMID AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE LNM CONTURA INTERNATIONAL A/S 50012 24F0501AA 05704101500128

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention| O| H