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

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.

• 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
• 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 Key: 9913213
• MDR Text Key: 194017797
• Report Number: 3003707320-2020-00005
• Device Sequence Number: 1
• Product Code: LMH
• UDI-Device Identifier: 10350224000025
• UDI-Public: (01)10350224000025(17)210124(10)F191078
• 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: Physician
• 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 Received: 04/01/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/24/2021
• Device Model Number: GBF0508
• Device Catalogue Number: GBF0508
• Device Lot Number: F191078
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/02/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/31/2019
• 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): Hospitalization; Required Intervention