MAUDE Adverse Event Report: CONTURA INTERNATIONAL A/S BULKAMID; AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE

Model Number	50050
Medical Device Problem Codes	Fluid/Blood Leak (1250); Obstruction of Flow (2423); Incomplete or Inadequate Connection (4037)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/09/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: imdrf code f1001 is being used to capture the reportable event of absence of treatment.Block h11: we are unable to provide the unique identifier (udi) # for this product.All available product data has been included in this report.The device was not returned for analysis; therefore, a technical analysis could not be performed.Based on the information provided, the most probable cause of the reported issue cannot be established due to lack of evidence.Since the investigation findings do not clearly confirm the presence or absence of the reported problem with the device, the investigation conclusion code selected for this complaint is unable to exclude device problem.
Event or Problem Description
It was reported that during the bulk amid injection, the clinical team encountered resistance while attempting to advance the bulking material through the needle.During this process, a leak of material was observed due to a failure of the luer-lock connection between the needle and the syringe.The physician was able to deliver approximately one full tube of material.Although partial delivery was achieved, the treatment was not considered optimal.According to the physician, two devices exhibited the issue.The patient was under general anesthesia at the time of the procedure.No additional patient complications were reported in association with this event.

• Brand Name: BULKAMID
• Common Device Name: AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE
• Manufacturer (Section D): CONTURA INTERNATIONAL A/S; sydmarken 23; soborg 2860 ; DA 2860
• Manufacturer (Section G): CONTURA INTERNATIONAL AS; sydmarken 23; soeborg 2860 ; DA 2860
• Manufacturer Contact: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 24713348
• Report Number: 2124215-2026-16913
• Device Sequence Number: 14872069
• Product Code: LNM
• UDI-Device Identifier: 10810005340509
• UDI-Public: (01)10810005340509
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: P170023
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/16/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 50050
• Device Catalogue Number: 50050
• Device Lot Number: AU2F242001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/25/2026
• Supplement Date Received by Manufacturer: 05/18/2026
• Initial Report FDA Received Date: 03/30/2026
• Supplement Report FDA Received Date: 06/16/2026
• Date Device Manufactured: 06/30/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 43 YR
• Patient Sex: Female
• Patient Weight: 59 KG