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

Model Number	50050
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hematoma (1884); Hemorrhage/Blood Loss/Bleeding (1888); Urinary Retention (2119)
Date of Event	02/10/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.
Event or Problem Description
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.

• 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: 24702032
• Report Number: 2124215-2026-16686
• Device Sequence Number: 13306215
• Product Code: LNM
• UDI-Device Identifier: 10810005340509
• UDI-Public: (01)10810005340509
• Combination Product (Y/N): N
• Initial Reporter State: MT
• Initial Reporter Country: US
• PMA/510(K) Number: P170023
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/26/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 50050
• Device Catalogue Number: 50050
• 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: 02/24/2026
• Initial Report FDA Received Date: 03/26/2026
• 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