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

Patient Problems Hematoma (1884); Urinary Retention (2119); Genital Bleeding (4507)

Event Date 08/18/2023

Event Type  Injury  

Event Description

Had bulkamid injected, i have been to multiple emergency room visits, and hospital admission.Had urine retention of 900cc had to use catheter for a week.Also have hematoma in vagina and bleeding every day.

• Brand Name: BULKAMID
• Type of Device: AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE
• Manufacturer (Section D): AXONICS, INC.
• MDR Report Key: 17692563
• MDR Text Key: 322870716
• Report Number: MW5145233
• 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: 08/31/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/05/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Was Device Available for Evaluation?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 50 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White