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); Insufficient Information (3190)

Patient Problems Emotional Changes (1831); Foreign Body Reaction (1868); Pain (1994); Rash (2033); Scar Tissue (2060); Depression (2361); Unspecified Eye / Vision Problem (4471)

Event Date 10/01/2020

Event Type  Injury  

Manufacturer Narrative

Multiple symptoms/issues reported by patient via (b)(6) dm after off-label bellafill dermal filler injection in (b)(6) 2020: patient report: "i was hoping to get some advice about my bellafill complication.I got one syringe of bellafill injected into two separate scars, spread out in two treatments with the last being (b)(6).The scars are not all that close together, one on apple of my check & one in between my nose & upper lip.The bellafill didn't improve the scar below my nose, but it also did not cause any problems.The scar on my cheek there was possibly some very slight improvement the first injection & no issues.But then the second injection things went bad.Looking back i'm wondering if it caused a reaction bc a few days after i got a spot like the one that caused the original scar right on top of the one that was injected.Not too long after i also developed quite a few lumps under my eye on the side of the scar & quite a bit of hardening around the scar that wasn't there before.I should also mention that i have always had good skin.These two spots i was getting treated were not acne according to my dermatologist (not my injector).I say that bc my skin also started breaking out shortly after with a terrible rash & my skin and was clear before.My injector said she would call me in a steroid pack to help with the lumps under my eye & luckily i asked her what it was bc she never called it in.My uncle is a dr so he called it in for me.It did nothing to help obviously.I've been on several antibiotics for this "rash" that's leaving me with more scars, only to have digestion issues now.It's to the point i won't even leave my house anymore unless i absolutely have to & it's a place i have to wear a mask.Too ashamed & depressed to work.This has caused me severe emotional distress & depression.So i am hoping y'all can help me with this.Since it's been 6 months my dr uncle is going to try & help me resolve this as i cannot live this way.He suggested i reach out to bellafill directly first.I have 2 boys (names and ages removed) & they need their happy mom back.I cannot afford surgery to remove the filler & wouldn't even know where to find a dr to do it as i live in (b)(6).One of the migration spots is tender to touch.My injector isn't helpful either.I feel like she's avoiding me because of the issues it caused & doesn't want to deal with it.I also have an upcoming eye dr app bc i feel like my vision is getting worse only on that side.& i don't wear glasses & have always had 20/20 or better." suneva is unable to obtain additional info after multiple attempts: on 4/30/21: suneva left a message at the phone number provided by the patient.On 5/10/21: no response.Suneva called the pt's number again.There was no pickup and a message could not be left.The mailbox was full.On 5/14/21: suneva called the pt's number again.No pickup and a message could not be left.The mailbox was full.On 5/20/21: suneva called the pt's number again.No pickup and a message could not be left.The mailbox was full.On 5/28/21: suneva called the pt's number again.No pickup and a message could not be left.The mailbox was full.No other (b)(6) dms have been received by suneva's social media team from this patient.They will, however, attempt to contact the patient again via dm to get either another number or an email address.Suneva will update this submission if any new information is received.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 patient relays they were injected in (b)(6) 2020, into two scars (not acne scars) in the apple of a cheek (with subsequent issues) and also between the nose and upper lip (without subsequent issues.No other information was provided at this time.Lot number and injector information are unknown.Bellafill use cannot be confirmed.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

Multiple symptoms/issues reported by patient via (b)(6) dm after off-label bellafill dermal filler injection in (b)(6) 2020: patient report: "i was hoping to get some advice about my bellafill complication.I got one syringe of bellafill injected into two separate scars, spread out in two treatments with the last being (b)(6).The scars are not all that close together, one on apple of my check & one in between my nose & upper lip.The bellafill didn't improve the scar below my nose, but it also did not cause any problems.The scar on my cheek there was possibly some very slight improvement the first injection & no issues.But then the second injection things went bad.Looking back i'm wondering if it caused a reaction bc a few days after i got a spot like the one that caused the original scar right on top of the one that was injected.Not too long after i also developed quite a few lumps under my eye on the side of the scar & quite a bit of hardening around the scar that wasn't there before.I should also mention that i have always had good skin.These two spots i was getting treated were not acne according to my dermatologist (not my injector).I say that bc my skin also started breaking out shortly after with a terrible rash & my skin and was clear before.My injector said she would call me in a steroid pack to help with the lumps under my eye & luckily i asked her what it was bc she never called it in.My uncle is a dr so he called it in for me.It did nothing to help obviously.I've been on several antibiotics for this "rash" that's leaving me with more scars, only to have digestion issues now.It's to the point i won't even leave my house anymore unless i absolutely have to & it's a place i have to wear a mask.Too ashamed & depressed to work.This has caused me severe emotional distress & depression.So i am hoping y'all can help me with this.Since it's been 6 months my dr uncle is going to try & help me resolve this as i cannot live this way.He suggested i reach out to bellafill directly first.I have 2 boys (names and ages removed) & they need their happy mom back.I cannot afford surgery to remove the filler & wouldn't even know where to find a dr to do it as i live in (b)(6).One of the migration spots is tender to touch.My injector isn't helpful either.I feel like she's avoiding me because of the issues it caused & doesn't want to deal with it.I also have an upcoming eye dr app bc i feel like my vision is getting worse only on that side.& i don't wear glasses & have always had 20/20 or better." suneva is unable to obtain additional info after multiple attempts.

• 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: 11905476
• MDR Text Key: 263583702
• Report Number: 3003707320-2021-00006
• Device Sequence Number: 1
• Product Code: LMH
• Combination Product (y/n): N
• PMA/PMN Number: P020012
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial
• Report Date: 05/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: GBF0508 (SUSPECTED)
• Device Catalogue Number: GBF0508 (SUSPECTED)
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/29/2021
• Initial Date FDA Received: 05/28/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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; Required Intervention; Disability