BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BULKAMID

    MDR report key: 19003051 · Received March 29, 2024

    Report

    Report Number
    19003051
    Event Type
    Malfunction
    Date Received
    March 29, 2024
    Date of Event
    January 5, 2024
    Report Date
    January 24, 2024
    Manufacturer
    CONTURA INTERNATIONAL A/S
    Product Code
    LNM
    UDI-DI
    05704101500500
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    SURGEON WAS ATTEMPTING TO INJECT BULKAMID INTO THE PATIENT, THE SHEATH WAS NOT FUNCTIONING PROPERLY SO THE BULKING AGENT WAS NOT ABLE TO BE INJECTED. THE OR NURSE HAD TO OPEN A SECOND BULKAMID KIT IN ORDER TO OPEN A NEW SHEATH. THE NEW SHEATH FUNCTIONED PROPERLY AND THE BULKING AGENT WAS ABLE TO BE PROPERLY INJECTED. THE REPRESENTATIVE FROM BULKAMID WAS CONTACTED AND MADE AWARE OF THE SITUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2589238 BULKAMID AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE LNM CONTURA INTERNATIONAL A/S 50050 23F1402AA 05704101500500

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Unknown