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

Model Number	50050
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/09/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that a bulkamid was used during a placement procedure performed on (b)(6) 2026.During the procedure, there was a leak from the syringe.It was reported as an unsuccessful implant.The type of anesthesia utilized was not reported.Boston scientific corporation has been unable to obtain additional information regarding this event, despite good faith efforts.There were no patient complications reported.
Additional Manufacturer Narrative
Block h6: impact code f1001 is being used to capture the reportable event of cancelled procedure, post sedation/unknown.
Additional Manufacturer Narrative
Block h6: impact code f1001 is being used to capture the reportable event of cancelled procedure, post sedation/unknown.Device evaluation: the device was not returned for analysis; therefore, a technical analysis could not be performed.The device history record (dhr) was provided by the sourced finished medical device (sfmd) confirmed that the device met all material, assembly and performance specifications.Based on a thorough review of the reported complaint, boston scientific has assigned an investigation conclusion code of cause not established has been chosen.
Event or Problem Description
It was reported to boston scientific corporation that a bulkamid was used during a placement procedure performed on (b)(6) 2026.During the procedure, there was a leak from the syringe.It was reported as an unsuccessful implant.The type of anesthesia utilized was not reported.Boston scientific corporation has been unable to obtain additional information regarding this event, despite good faith efforts.There were no patient complications reported.

• 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 A/S; sydmarken 23; soborg 2860 ; DA 2860
• Manufacturer Contact: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 24570743
• Report Number: 2124215-2026-13626
• Device Sequence Number: 8384191
• Product Code: LNM
• UDI-Device Identifier: 10810005340509
• UDI-Public: (01)10810005340509(17)271130(10)AU2F244202
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: P170023
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 04/21/2026

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: AU2F244202
• 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: 02/09/2026
• Supplement Date Received by Manufacturer: 03/25/2026
• Initial Report FDA Received Date: 03/11/2026
• Supplement Report FDA Received Date: 04/21/2026
• Date Device Manufactured: 11/30/2024
• 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 Sex: Unknown