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

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Pain (1994); Swelling (2091); Discomfort (2330); Deformity/ Disfigurement (2360)

Event Date 06/06/2019

Event Type  Injury  

Event Description

I had bellafill over a year and a half ago with no issues. Out of the blue my face swelled up, the areas where bellafill was became rock hard and tender to touch. It felt like my skin was going to rip. I now look disfigured. I ended up going to emergency room.

• Brand Name: BELLAFILL
• Type of Device: IMPLANT, DERMAL, FOR AESTHETIC USE
• Manufacturer (Section D): SUNEVA MEDICAL, INC.
• MDR Report Key: 8707891
• MDR Text Key: 148455596
• Report Number: MW5087426
• Device Sequence Number: 1
• Product Code: LMH
• Combination Product (y/n): Y
• 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: 06/13/2019

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 06/17/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No Answer provided

Was the Report Sent to FDA?

• Event Location: No Information

Was Device Evaluated by Manufacturer?

Is the Device Single Use?

Is This a Reprocessed and Reused Single-Use Device?

Type of Device Usage