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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
Device Problem Insufficient Information (3190)
Patient Problem Patient Problem/Medical Problem (2688)
Event Date 02/07/2020
Event Type  Injury  
Manufacturer Narrative
Patient relayed deformation to the doctor about 2 weeks after bellafill injection, but will not allow the doctor to examine to determine cause or diagnosis. Patient states they require surgery to correct. Timeline: on (b)(6) 2020: the patient was injected with bellafill dermal filler in the "marionette lines, jowls, and parenthesis lines". On (b)(6) 2020: the patient reported the deformation to the doctor. The actual onset date is unknown. The area(s) of "deformation" is unknown. On (b)(6) 2020: date the issue was reported to (b)(6). Known patient medical history per the reporting account: patient states no known medical conditions. No known drug allergies. Currently takes no medications. No other fillers or facial treatments per the injector's knowledge. The lot used in the patient's bellafill procedure (lot f191096) was reviewed. No issues were noted with manufacturing records, the lot met all acceptance criteria upon release. Review of the retained lot samples for lot f191096 found the lot continues to meet release criteria. The patient has refused to come back to the injector for examination as of the date of this submission. The cause of the reported deformation is unknown. The patient was injected with bellafill dermal filler in the "marionette lines, jowls, and parenthesis lines". The area(s) of "deformation" is unknown. Bellafill dermal filler is indicated for the correction of nasolabial folds and moderate to severe, atrophic, distensible facial acne scars on the cheek in patients over the age of 21 years. Bellafill syringes are single use devices and are typically discarded after use. Per the bellafill ifu: "the syringe and any unused material should be discarded after a single treatment visit. ".
 
Event Description
Patient relayed deformation to the doctor about 2 weeks after bellafill injection, but will not allow the doctor to examine to determine cause or diagnosis. Patient states they require surgery to correct.
 
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Brand NameBELLAFILL DERMAL FILLER
Type of DeviceIMPLANT, DERMAL, FOR AESTHETIC USE
Manufacturer (Section D)
SUNEVA MEDICAL, INC.
5870 pacific center blvd.
san diego, ca
Manufacturer (Section G)
SUNEVA MEDICAL, INC.
5870 pacific center blvd.
san diego, ca
Manufacturer Contact
stacy lewis
5870 pacific center blvd.
san diego, ca 
7685492
MDR Report Key9832865
MDR Text Key196412922
Report Number3003707320-2020-00004
Device Sequence Number1
Product Code LMH
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P020012
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation Nurse Practitioner
Type of Report Initial
Report Date 03/13/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/14/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date03/17/2021
Device Model NumberGBF0508
Device Catalogue NumberGBF0508
Device Lot NumberF191096
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/14/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/26/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 03/14/2020 Patient Sequence Number: 1
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