MAUDE Adverse Event Report: AXONICS, INC BULKAMID URETHRAL BULKING SYSTEM; 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 Code	Hematuria (2558)
Date of Event	07/28/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient had hematuria and clot retention two days post bulkamid procedure.
Event or Problem Description
See section h, number 6 for the investigation conclusion code updated.

• Brand Name: BULKAMID URETHRAL BULKING SYSTEM
• Common Device Name: AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE
• Manufacturer (Section D): AXONICS, INC; 26 technology dr; irvine CA 92618
• Manufacturer (Section G): CONTURA INTERNATIONAL A/S; 23 sydmarken; soeborg
• Manufacturer Contact: linda phan ; 26 technology drive; irvine, CA 92618
• MDR Report Key: 17596938
• Report Number: 3002968685-2023-00104
• Device Sequence Number: 6534815
• Product Code: LNM
• UDI-Device Identifier: 05704101500500
• UDI-Public: 05704101500500
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P170023
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/11/2023

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
• Device Model Number: 50050
• Device Lot Number: 22F2302AA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/09/2023
• Supplement Date Received by Manufacturer: 08/09/2023
• Initial Report FDA Received Date: 08/22/2023
• Supplement Report FDA Received Date: 10/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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