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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 Problems Off-Label Use (1494); Improper or Incorrect Procedure or Method (2017)
Patient Problems Patient Problem/Medical Problem (2688); No Code Available (3191)
Event Date 06/01/2018
Event Type  Injury  
Manufacturer Narrative
The patient was injected with bellafill dermal filler off-label under the eyes about 3 years ago. On (b)(6) 2019, the patient reported to suneva yellow discoloration under the eyes which had first appeared in (b)(6) 2018. On (b)(6) 2019, after discussion with the injector, the discoloration was determined to be xanthelasma. While xanthelasma is not harmful, it does require treatment to resolve. The bellafill lot numbers used in the patient's procedure are unknown at this time and bellafill use has not been confirmed. Suneva will continue to attempt to obtain the lot numbers from the account. The patient denies any medical conditions or medications. Injections under the eyes is off-label for bellafill. Dr. (b)(6) is aware of bellafill indications for use. 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. The exact age of the patient is unknown, however she is over 21. 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
The patient was injected with bellafill dermal filler off-label under the eyes about 3 years ago. On (b)(6) 2019, the patient reported yellow discoloration under the eyes which had first appeared in (b)(6) 2018. The discoloration was determined to be xanthelasma. Xanthelasma requires treatment to resolve.
 
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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 CA 92121
Manufacturer (Section G)
SUNEVA MEDICAL, INC.
5870 pacific center blvd.
san diego, ca CA 92121
Manufacturer Contact
stacy lewis
5870 pacific center blvd.
san diego, ca, CA 92121
8587685492
MDR Report Key9628617
MDR Text Key188484772
Report Number3003707320-2020-00001
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
Type of Report Initial,Followup
Report Date 01/24/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/24/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberGBF0508 (SUSPECTED)
Device Catalogue NumberGBF0508 (SUSPECTED)
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/27/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/01/2017
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: 01/24/2020 Patient Sequence Number: 1
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