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

Lot Number 22F1602

Patient Problems Hypersensitivity/Allergic reaction (1907); Itching Sensation (1943); Rash (2033)

Event Date 11/03/2023

Event Type  Injury  

Event Description

On (b)(6) 2023, i had urethral bulkamid injections.By evening of (b)(6) 2023, i was itching and was starting to break out in a rash.The rash continued to spread across my body through out the following days.I have had multiple doctors' visits, lab tests, and medications, including at least four courses of prednisone.I still have rash.Even though i have finished my fourth course of prednisone, this time for 6 weeks.I am in my fourth month of having a rash (very itchy).I think i am experiencing a reaction to having this bulkamid gel inside me.Multiple lab tests have been run to eliminate or find what is the cause of this ongoing rash; including punch biopsy of rash site.No other existing health conditions have been found.Ref reports: mw5152649, mw5152651, mw5152652.

• Brand Name: BULKAMID INJECTABLE IMPLANT
• Type of Device: AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE
• Manufacturer (Section D): AXONICS, INC.
• MDR Report Key: 18886547
• MDR Text Key: 337596235
• Report Number: MW5152650
• 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: 02/27/2024

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 Lot Number: 22F1602
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/11/2024
• Patient Sequence Number: 1
• Treatment: ACETAMINOPHEN ; CETIRIZONE; FAMOTIDINE; FEXOFENADINE; GLIMEPIRIDE; HYDROXYZINE; KENALOG ; SINGULAIR; TERAZOSIN
• Patient Outcome(s): Other
• Patient Age: 71 YR
• Patient Sex: Female
• Patient Weight: 95 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White