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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SUNEVA MEDICAL, INC. BELLAFILL DERMAL FILLER; IMPLANT, DERMAL, FOR AESTHETIC USE
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SUNEVA MEDICAL, INC. BELLAFILL DERMAL FILLER; IMPLANT, DERMAL, FOR AESTHETIC USE Back to Search Results
Model Number GBF0508 (SUSPECTED)
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Patient Problem/Medical Problem (2688)
Event Type  Injury  
Manufacturer Narrative
Patient reported "permanent marks" after off-label injection under the eyes.Patient states that her injector is aware of the issue and tried to "fix it" but it did not do anything.She is not going back to the injector who she would not name.She also relayed that she had a 2nd opinion by a plastic surgeon (who she would not name) who said to wait and that it would probably fade away over a period of years.He also relayed to the patient that it was inoperable and would look worse after surgery.Patient would not provide additional information stating she didn't see the point in reporting.Lot number and injector are unknown.Bellafill use cannot be confirmed.Bellafill is indicated for correction of the nasolabial folds and acne scars in the cheeks.
 
Event Description
Patient reported "permanent marks" under the eyes after off-label bellafill injection.
 
Manufacturer Narrative
Patient reported "permanent marks" after off-label injection under the eyes.Patient states that her injector is aware of the issue and tried to "fix it" but it did not do anything.She is not going back to the injector who she would not name.She also relayed that she had a 2nd opinion by a plastic surgeon (who she would not name) who said to wait and that it would probably fade away over a period of years.He also relayed to the patient that it was inoperable and would look worse after surgery.Patient would not provide additional information stating she didn't see the point in reporting.Lot number and injector are unknown.Bellafill use cannot be confirmed.Bellafill is indicated for correction of the nasolabial folds and acne scars in the cheeks.Follow-up #1: corrected information.The suspected model/catalog # is gbf0508.
 
Event Description
Patient reported "permanent marks" under the eyes after off-label bellafill injection.
 
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Brand Name
BELLAFILL DERMAL FILLER
Type of Device
IMPLANT, DERMAL, FOR AESTHETIC USE
Manufacturer (Section D)
SUNEVA MEDICAL, INC.
5870 pacific center blvd.
san diego CA 92121
MDR Report Key7467383
MDR Text Key106694966
Report Number3003707320-2018-00007
Device Sequence Number1
Product Code LMH
Combination Product (y/n)N
PMA/PMN Number
P020012
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Type of Report Initial,Followup
Report Date 04/26/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/26/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator No Information
Device Model NumberGBF0508 (SUSPECTED)
Device Catalogue NumberGBF0508 (SUSPECTED)
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Date Manufacturer Received03/26/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Disability;
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