BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BULKAMID

    MDR report key: 22873539 · Received August 22, 2025

    Report

    Report Number
    2124215-2025-58806
    Event Type
    Injury
    Date Received
    August 22, 2025
    Date of Event
    March 1, 2025
    Report Date
    August 22, 2025
    Manufacturer
    CONTURA INTERNATIONAL A/S
    Product Code
    LNM
    UDI-DI
    10810005340509
    PMA / PMN Number
    P170023
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK B3: THE EXACT DATE OF THE EVENT IS UNKNOWN. THE REPORTED DATE, 03/01/2025, WAS SELECTED AS THE BEST ESTIMATE BASED ON THE INFORMATION INDICATING WHEN THE PATIENT RECEIVED THE DEVICE. 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 RECEIVED BULKAMID URETHRAL BULKING SYSTEM SOMETIME IN (B)(6) 2025. FOLLOWING THE PROCEDURE, THE PATIENT EXPERIENCED URINARY RETENTION AND REQUIRED CLEAN INTERMITTENT CATHETERIZATION (CIC) FOR THREE DAYS. SHE CONTINUED TO EXPERIENCE DIFFICULTY EMPTYING HER BLADDER, WITH ELEVATED POST-VOID RESIDUAL (PVR) VOLUMES, ALTHOUGH SPECIFIC MEASUREMENTS WERE NOT AVAILABLE. ADDITIONALLY, THE PATIENT REPORTED A WORSENING OF HER STRESS URINARY INCONTINENCE (SUI) COMPARED TO HER CONDITION PRIOR TO THE PROCEDURE. AS OF THE TIME OF THIS REPORT, IT IS UNKNOWN WHETHER THE PATIENT'S SYMPTOMS HAVE RESOLVED. BOSTON SCIENTIFIC CORPORATION HAS BEEN UNABLE TO OBTAIN ADDITIONAL INFORMATION REGARDING THIS EVENT, DESPITE GOOD FAITH EFFORTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2618807 BULKAMID AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE LNM CONTURA INTERNATIONAL A/S 50050 10810005340509

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female