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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 Problems Off-Label Use (1494); Use of Device Problem (1670)
Patient Problems Anaphylactoid (2218); Patient Problem/Medical Problem (2688)
Event Date 02/28/2020
Event Type  Injury  
Manufacturer Narrative
Potential anaphylactic reaction leading to emergency room visit and medication. Timeline: on (b)(6) 2020: the bellafill skin test was done (2 weeks prior to the bellafill dermal filler injections on (b)(6) 2020). The account was advised that the skin test is a 28-day (4-week) test and symptoms can occur at any point during that timeframe. The skin tested area felt itchy, but no redness, so they proceeded with the bellafill dermal filler injections. The patient also subsequently developed a rash on both arms, on (b)(6) 2020: patient was injected off-label in the bilateral temples, bilateral periocular areas, and bilateral chin. She washed her face with a chlorhexidine wash prior to the bellafill injections. 30 mins after injection she was driving and felt like her throat was closing, was having trouble swallowing, and her tongue felt like it was thickening. She drove herself to the er and they put her on steroids. They prescribed prednisone, benadryl. They also prescribed an epi pen which the patient stated that she has not used. On (b)(6) 2020: initial report received. The patient went to the er again earlier today when she felt the same symptoms were coming on. The patient also relays that her eyes are currently very puffy and feel very heavy, lips and cheeks are numb. The patient was advised to return to the er as needed. On (b)(6) 2020: as of (b)(6) 2020, the patient is still on prednisone and antihistamines. She's on a prednisone taper from 60 to 10. She's now on 10. She has a puffy face from the steroids, but otherwise is doing well. She is being testing to determine if she's allergic to the lidocaine or the collagen. Test results expected the following week (b)(6) 2020) and indicate they will email the results. Patient medical history: previously had "revanese versa" dermal filler, botox, dysport without issues in different areas. About 8 weeks prior to the report, the patient had a ruptured ectopic pregnancy, which was very traumatic. She says that when her current symptoms came on, she was "being super cautious" because she had ignored the symptoms with the ectopic pregnancy that had almost became fatal. Three (3) bellafill lots were used in the patient's procedure: f191078: udi: (b)(4), expires 01/24/2021; manufacture date: 07/31/2019. F191079: udi: (b)(4), expires 01/30/2021, manufacture date: 08/05/2019. F191111: udi: (b)(4), expires 05/15/2021, manufacture date: 11/22/2019. Lot reviews: review of manufacturing records found all lots were manufactured according to approved work instructions and met all acceptance criteria upon release. Review of retained lot samples found all lots continue to meet release criteria. This is the first report related to allergy or anaphylactic response for all 3 lots. 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 bellafill skin test is intended to be administered intradermally into the volar forearm to identify individuals who might show hypersensitivity to injectable bovine dermal collagen devices. Patients so identified are ineligible for treatment with bellafill. Per the bellafill skin test ifu: the results of the skin test must be carefully evaluated for a 4-week period prior to the initiation of treatment with bellafill. Patients should be instructed to notify their physicians of any untoward test response observed within the 4-week period. 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
Potential anaphylactic reaction leading to emergency room visit and medication.
 
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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
pam misajon
5870 pacific center blvd.
san diego, ca 
7685492
MDR Report Key9913213
MDR Text Key194017797
Report Number3003707320-2020-00005
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
Report Date 04/01/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/01/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date01/24/2021
Device Model NumberGBF0508
Device Catalogue NumberGBF0508
Device Lot NumberF191078
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 Received03/02/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/31/2019
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: 04/01/2020 Patient Sequence Number: 1
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