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

Model Number GBF0508 (SUSPECTED)

Device Problem Insufficient Information (3190)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 01/01/2018

Event Type  Injury  

Manufacturer Narrative

Patient relays via voicemails that about 3 mos.After her bellafill injections she had a late onset reaction/systemic inflammatory allergic response that she is being treated for and is on-going she also relays that she had a pre-existing illness she wasn't aware of until after her injections ~1 1/2 years ago and this has "almost cost her life on a couple of occasions now".She feels ill in the morning and better in the evening.She also relays that she had 3 different medical treatments in the last month in 3 different cities in 3 different states in the u.S.Timeline: (b)(6) 2019 - suneva received voicemail from patient - she relays that ~3 mos.After her bellafill injections (~1 1/2 years ago) in her nasolabial folds and "face", she had a late onset reaction/ systemic inflammatory allergic response for which she had been bedridden.She also relays that she had a pre-existing illness she wasn't aware of until after her injections and this has "almost cost her life on a couple of occasions now".She is looking for a doctor in los angeles to remove the product from her face.Suneva left messages on the patient's phone on the following dates; providing both phone number and email address to elicit a response: (b)(6) 2019, no response from the patient.(b)(6) 2019, no response from the patient.(b)(6) 2019, no response from the patient.(b)(6) 2019, no response from the patient.(b)(6) 2019, patient responded on (b)(6) 2019.On (b)(6) 2019, the patient responded and left another voicemail relaying that she feels ill in the morning and better in the evening.She also relays that she had 3 different medical treatments in the last month in 3 different cities in 3 different states in the u.S.And has spent (b)(6) of dollars to keep her alive.She indicates she will not be providing further info as she is not sure of the benefit in speaking with suneva and she is on her way to (b)(6) to start a treatment.On (b)(6) 2019, suneva left a text on the patient's phone, with phone # and email address, asking if there can be a conversation via email.No further info has been received at the time of this submission.Suneva will continue to attempt to reach the patient and investigate this report.If additional info is received, suneva will provide a follow-up report to this submission.Suneva is unable to investigate further at this time.The bellafill injector is unknown, bellafill use cannot be confirmed, and the locations of all injections and the patients medical history (i.E.Nature of the pre-existing illness) is unknown.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." in (b)(6), bellafill dermal filler is indicated for the correction of nasolabial folds.

Event Description

Patient relays via voicemails that about 3 mos.After her bellafill injections she had a late onset reaction/systemic inflammatory allergic response that she is being treated for and is on-going she also relays that she had a pre-existing illness she wasn't aware of until after her injections ~1 1/2 years ago and this has "almost cost her life on a couple of occasions now".She feels ill in the morning and better in the evening.She also relays that she had 3 different medical treatments in the last month in 3 different cities in 3 different states in the u.S.

• 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: 8972815
• MDR Text Key: 161380656
• Report Number: 3003707320-2019-00015
• 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: 09/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/06/2019
• 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
• Date Manufacturer Received: 08/09/2019
• 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): Life Threatening; Required Intervention