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	Urinary Retention (2119); Urinary Incontinence (4572)
Date of Event	03/01/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Block b3: the exact date of the event is unknown.The reported date, 03/01/2025, was selected as the best estimate based on the information indicating when the patient received the device.Blocks d4 and h4: the complainant was unable to report the lot number; therefore, the manufacture date and expiration date are unknown.Block h6: device code e1309 is being used to capture the reportable event of urinary retention.Block h11: 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.
Event or Problem Description
It was reported that a patient received bulkamid urethral bulking system sometime in (b)(6) 2025.Following the procedure, the patient experienced urinary retention and required clean intermittent catheterization (cic) for three days.She continued to experience difficulty emptying her bladder, with elevated post-void residual (pvr) volumes, although specific measurements were not available.Additionally, the patient reported a worsening of her stress urinary incontinence (sui) compared to her condition prior to the procedure.As of the time of this report, it is unknown whether the patient's symptoms have resolved.Boston scientific corporation has been unable to obtain additional information regarding this event, despite good faith efforts.

• 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: 22873539
• Report Number: 2124215-2025-58806
• Device Sequence Number: 5803109
• Product Code: LNM
• UDI-Device Identifier: 10810005340509
• UDI-Public: (01)10810005340509
• Combination Product (Y/N): N
• Initial Reporter State: KY
• 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
• Report Date (Section B): 08/22/2025

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: 07/24/2025
• Initial Report FDA Received Date: 08/22/2025
• 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: Female