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

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.

• 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 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 Key: 9628617
• MDR Text Key: 188484772
• Report Number: 3003707320-2020-00001
• Device Sequence Number: 1
• Product Code: LMH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P020012
• Number of Events Reported: 1
• 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 Received: 01/24/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Model Number: GBF0508 (SUSPECTED)
• Device Catalogue Number: GBF0508 (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 Received: 12/27/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2017
• 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