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

Model Number 50050

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Subcutaneous Nodule (4548)

Event Date 05/09/2022

Event Type  Injury  

Event Description

The patient underwent a device revision due to a ¿cyst¿ discovered paraurethral.

• Brand Name: BULKAMID URETHRAL BULKING SYSTEM
• Type of Device: AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE
• Manufacturer (Section D): AXONICS MODULATION TECHNOLOGIES, INC.; 26 technology dr; irvine CA
• Manufacturer (Section G): CONTURA INTERNATIONAL A/S; 23 sydmarken; soeborg 2860 ; DK 2860
• Manufacturer Contact: cherilyn johnson ; 26 technology drive; irvine, CA ; 9493366329
• MDR Report Key: 14594914
• MDR Text Key: 293288079
• Report Number: 3002968685-2022-00050
• Device Sequence Number: 1
• Product Code: LNM
• Combination Product (y/n): N
• 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
• Report Date: 06/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/03/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 50050
• Date Manufacturer Received: 05/12/2022
• 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