BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BULKAMID

    MDR report key: 23271478 · Received October 10, 2025

    Report

    Report Number
    2124215-2025-72159
    Event Type
    Injury
    Date Received
    October 10, 2025
    Date of Event
    September 11, 2025
    Report Date
    October 10, 2025
    Manufacturer
    CONTURA INTERNATIONAL A/S
    Product Code
    LNM
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCKS D4 AND H4: THE COMPLAINANT WAS UNABLE TO REPORT THE LOT NUMBER; THEREFORE, THE MANUFACTURE DATE AND EXPIRATION DATE ARE UNKNOWN. BLOCK H6: DEVICE CODE E1309 IS BEING USED TO CAPTURE THE REPORTABLE EVENT OF URINARY RETENTION. BLOCK H11: DETAILED PRODUCT INFORMATION WAS NOT PROVIDED TO BSC. WE COMPLETED A GOOD FAITH EFFORT TO OBTAIN THE INFORMATION. BECAUSE THE PRODUCT IS UNKNOWN AT THIS TIME, WE ARE UNABLE TO PROVIDE THE COMPLETE UNIQUE IDENTIFIER (UDI) # AND OTHER PRODUCT SPECIFIC INFORMATION. IF ADDITIONAL DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT IN HER LATE 50S EXPERIENCED SIGNIFICANT URINARY RETENTION FOLLOWING TREATMENT WITH THE BULKAMID DEVICE. THE INJECTION WAS ADMINISTERED APPROXIMATELY SIX WEEKS PRIOR TO THE REPORT DATE, AROUND EARLY (B)(6) 2025. SINCE THE PROCEDURE, THE PATIENT HAS EXPERIENCED PERSISTENT RETENTION WITH NO IMPROVEMENT, DESPITE CATHETERIZATION. THE PATIENT CURRENTLY RETAINS BETWEEN 200-300 ML OF URINE POST-VOID AND REQUIRES CLEAN INTERMITTENT SELF-CATHETERIZATION (CISC) TWICE DAILY TO FULLY EMPTY HER BLADDER. HER SYMPTOMS HAVE PERSISTED WITHOUT IMPROVEMENT SINCE ONSET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2421147 BULKAMID AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE LNM CONTURA INTERNATIONAL A/S

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Other| R