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

Patient Problem Incontinence (1928)

Event Date 11/14/2023

Event Type  malfunction  

Event Description

Hello fda, on (b)(6) 2023 i had cystoscopy with urethral bulkamid injection under general anesthesia in the operating room for stress urinary incontinence.While the bulkamid injection seemed to work initially, the effects wore off completely after 1 month.But the worst part is that my incontinence is now worse.I had a cold virus 1 month after the procedure around (b)(6) 2023, and now have incontinence every time i cough which is much worse.I want to make a formal complaint about the long term effectiveness of bulkamid and that is doing harm once the brief period of effectiveness wears off.My physician urologist is dr.(b)(6).Thank you, (b)(6).

• Brand Name: BULKAMID
• Type of Device: AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE
• Manufacturer (Section D): AXONICS, INC.
• MDR Report Key: 18274646
• MDR Text Key: 330002060
• Report Number: MW5148863
• Device Sequence Number: 1
• Product Code: LNM
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 12/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/05/2023
• Patient Sequence Number: 1
• Treatment: CALCIUM.; DOXEPIN.; FISH OIL.; LEXAPRO.; MULTI-VITAMIN.; TRAZODONE.
• Patient Outcome(s): Other
• Patient Age: 51 YR
• Patient Sex: Female
• Patient Weight: 61 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White