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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 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 (b)(4) 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 (b)(4), received in-house at suneva on 3/3/2022. Background: (b)(6) 2021: patient (initials a. M. ) 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. Rivkin 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. Rivkin 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 (b)(4) 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. ".
 
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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 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 Key13983052
MDR Text Key293634852
Report Number3003707320-2022-00003
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 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 Received04/01/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberGBF0508
Device Catalogue NumberGBF0508
Device Lot NumberF211044
Was Device Available for Evaluation? No
Date Manufacturer Received03/03/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/03/2021
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: 04/01/2022 Patient Sequence Number: 1
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