MAUDE Adverse Event Report: SUNEVA MEDICAL, INC. BELLAFILL IMPLANT, DERMAL, FOR AESTHETIC USE

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

Patient Problems Erythema (1840); Skin Inflammation/ Irritation (4545); Swelling/ Edema (4577)

Event Date 12/01/2021

Event Type  Injury  

Event Description

Bellafill injection has caused me to experience continued inflammatory response, inclusive of swelling and redness of skin. Given it's permanent nature, once placed under skin, there is no antidote to reverse. It is marketed as a 5 year filler but by nature of its composition, it is permanent. This is very deceiving for the consumer. There are hundreds of patients suffering for unsightly inflammatory reactions, granulomas and nodules. The medical community at large does not know how to manage these adverse events. Fda safety report id# (b)(4).

• Brand Name: BELLAFILL
• Type of Device: IMPLANT, DERMAL, FOR AESTHETIC USE
• Manufacturer (Section D): SUNEVA MEDICAL, INC.
• MDR Report Key: 13425112
• MDR Text Key: 285013484
• Report Number: MW5107137
• Device Sequence Number: 1
• Product Code: LMH
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 01/28/2022

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 02/01/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No Answer provided