MAUDE Adverse Event Report: AXONICS, INC BULKAMID URETHRAL BULKING SYSTEM; AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE

Model Number 50050

Device Problem Unexpected Therapeutic Results (1631)

Patient Problem Urinary Tract Infection (2120)

Event Type  Injury  

Event Description

The patient was treated with antibiotics for uti after a bulkamid procedure.

• Brand Name: BULKAMID URETHRAL BULKING SYSTEM
• Type of Device: 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 ; DK
• Manufacturer Contact: azucena eulloqui ; 26 technology drive; irvine, CA 92618
• MDR Report Key: 17243164
• MDR Text Key: 318263938
• Report Number: 3002968685-2023-00088
• Device Sequence Number: 1
• Product Code: LNM
• UDI-Device Identifier: 05704101500500
• UDI-Public: 05704101500500
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P170023
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/30/2023

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 Operator: Health Professional
• Device Model Number: 50050
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/14/2023
• Initial Date FDA Received: 06/30/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Sex: Female