BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BULKAMID

    MDR report key: 24772820 · Received April 3, 2026

    Report

    Report Number
    2124215-2026-18301
    Event Type
    Injury
    Date Received
    April 3, 2026
    Date of Event
    February 12, 2026
    Report Date
    April 29, 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
    NY, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    IMDRF IMPACT CODE F1901 CAPTURES THE REPORTABLE EVENT OF ADDITIONAL SURGERY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A FOLLOW UP ROUTINE AFTER BULKAMID PROCEDURE, THE PHYSICIAN REPORTED A PROBLEM WITH THE DEVICE. THE PHYSICIAN PERFORMED AN ADDITIONAL PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    6565 BULKAMID AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE LNM CONTURA INTERNATIONAL A/S 50050 AU2F244202 10810005340509

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention