• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

SUNEVA MEDICAL, INC. BELLAFILL IMPLANT, DERMAL, FOR AESTHETIC USE Back to Search Results
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.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameBELLAFILL
Type of DeviceIMPLANT, DERMAL, FOR AESTHETIC USE
Manufacturer (Section D)
SUNEVA MEDICAL, INC.
MDR Report Key8707891
MDR Text Key148455596
Report NumberMW5087426
Device Sequence Number1
Product Code LMH
Combination Product (y/n)Y
Reporter Country CodeUS
Number of Events Reported1
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 Received06/17/2019
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

-
-