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

Model Number GBF0508

Device Problem Off-Label Use (1494)

Patient Problems Erythema (1840); Skin Inflammation/ Irritation (4545); Swelling/ Edema (4577)

Event Date 12/01/2021

Event Type  Injury  

Manufacturer Narrative

Medwatch mw5107137 issued by patient for "serious injury - erythema, skin inflammation/irritation, swelling/edema"; received on 3/3/22.Event description: "bellafill injection has caused me to experience continued inflammatory response, inclusive of swelling and redness of skin.Given its permanent nature, once placd under skin, there is no antidote to reverese.It is marketed as a 5 year filler but by nature of its composition, it is permanent.This is very deciving for the consumer.Thre are hundreds of patients suffereing for unsightly inflammatory reactions, granulomas and nodules.The medical community at large does not know how to manage these adverse events." suneva medical is responding to the patient-filed medwatch mw5107137, received in-house at suneva on 3/3/2022.Background: (b)(6) 2021: patient (initials (b)(6)) reported swelling after off-label bellafill injection in the nose via social media, only instagram username was available.No contact info received yet.(b)(6) 2021: patient provided contact info and suneva medical followed up with the patient.(b)(6) 2021: patient responded that she was injected on (b)(6) 2021 in with one syirnge of bellafill.Swelling was immediate.She also had a bellafill skin test on (b)(6) 2021; no report of redness/swelling at skin test site.She states she has contacted her injector ((b)(6)) with her current symptoms.No treatment was given and dr.(b)(6) advised her to wait 2-3 months.Patient relayed she has had other procedures on/in the nose besides bellafill, "multiple rhinoplasties".The patient provided permission to follow up with her injector.(b)(6) 2021: suneva spoke with the injecting office.The injector was dr.(b)(6) and the lot was f211044.The patient was injected off-label in the nose and swelling there is not unusual so soon after injection.The patient had been advised to wait and see.(b)(6) 2022: batch review of lot f211044 was completed.No issues noted with retained samples or with manufacturing records.This was the first patient event reported for this lot.(b)(6) 2022: patient was notified of results.(b)(6) 2022: suneva received medwatch mw5107137, which aligned with the complaint file opened on 12/14/21.The medwatch with its new info was added to the complaint file.An emdr was scheduled in 30 calendar days.(b)(6) 2022: suneva spoke with the injecting account who state they last saw the patient in (b)(6) 2022 (exact date was not provided) and decided to inject a steroid to address the patient's concerns.They did not have any results from the steriod injection and had not heard from the patient since.Per the bellafill instrucitons for use (ifu): the 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.Inflammatory responses, such as swelling and redness are anticipated patient events that are documented in the bellafill ifu.Clinical studies support that these issues may resolve with or without treatment.Per the bellafill ifu: "four (4) weeks prior to treatment, patients will be given a 0.1cc test injection of bellafill® skin test material subcutaneously in the volar forearm, to determine a patient's sensitivity to the treatment material." bellafill syringes are single use devices that 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

Medwatch mw5107137 issued by patient for "serious injury - erythema, skin inflammation/irritation, swelling/edema"; received on 3/3/22.Event description: "bellafill injection has caused me to experience continued inflammatory response, inclusive of swelling and redness of skin.Given its permanent nature, once placed under skin, there is no antidote to reverse.It is marketed as a 5 year filler but by nature of its composition, it is permanent.This is very deceiving for the consumer.There are hundreds of patients suffering for unsightly inflammatory reactions, granulomas and nodules.The medical community at large does not know how to manage these adverse events.".

• 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
• Manufacturer (Section G): SUNEVA MEDICAL, INC.; 5870 pacific center blvd.; san diego CA 92121
• Manufacturer Contact: stacy lewis ; 5870 pacific center blvd.; san diego, CA 92121 ; 8587685492
• MDR Report Key: 13983052
• MDR Text Key: 293634852
• Report Number: 3003707320-2022-00003
• Device Sequence Number: 1
• Product Code: LMH
• UDI-Device Identifier: 10350224000025
• UDI-Public: (01)10350224000025(17)221120(10)F211044
• 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: Other
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 04/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/01/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/20/2022
• Device Model Number: GBF0508
• Device Catalogue Number: GBF0508
• Device Lot Number: F211044
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/03/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/03/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Female