BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BULKAMID

    MDR report key: 24702032 · Received March 26, 2026

    Report

    Report Number
    2124215-2026-16686
    Event Type
    Injury
    Date Received
    March 26, 2026
    Date of Event
    February 10, 2026
    Report Date
    March 26, 2026
    Manufacturer
    CONTURA INTERNATIONAL A/S
    Product Code
    LNM
    UDI-DI
    10810005340509
    PMA / PMN Number
    P170023
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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. BLOCK H6: IMDRF PATIENT CODE E0506 CAPTURES THE REPORTABLE EVENT OF BLEEDING. IMDRF PATIENT CODE E1309 CAPTURES THE REPORTABLE EVENT OF URINARY RETENTION. IMDRF PATIENT CODE E0505 CAPTURES THE REPORTABLE EVENT OF HEMATOMA.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT WHO UNDERWENT BULKAMID IMPLANTATION, REPORTED HAVING RETENTION AND VAGINAL BLEEDING. SHE WAS SEEN BY ANOTHER PHYSICIAN DUE TO THE RETENTION, AND IT WAS DETERMINED THAT THERE WAS A LARGE HEMATOMA BETWEEN THE URETHRA AND THE VAGINA. THE PATIENT HAD A CATHETER PLACED. THE ISSUE WAS REPORTED AS ONGOING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    756554 BULKAMID AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE LNM CONTURA INTERNATIONAL A/S 50050 10810005340509

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown