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

Model Number 50012

Device Problem Insufficient Information (3190)

Patient Problem Urinary Retention (2119)

Event Date 01/29/2024

Event Type  Injury  

Event Description

The patient has urinary retention which resulted in catheterization.

Event Description

See section h, number 6 for investigation updates.

• 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 Contact: linda phan ; 26 technology dr; irvine, CA 92618
• MDR Report Key: 18798867
• MDR Text Key: 336457943
• Report Number: 3002968685-2024-00034
• Device Sequence Number: 1
• Product Code: LNM
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: P170023
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/06/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 50012
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/01/2024
• 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 Outcome(s): Required Intervention
• Patient Sex: Female