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

Model Number GBF0508 (SUSPECTED)

Device Problem Off-Label Use (1494)

Patient Problems Pain (1994); Nerve Proximity Nos (Not Otherwise Specified) (2647); Patient Problem/Medical Problem (2688)

Event Date 05/01/2019

Event Type  Injury  

Manufacturer Narrative

Patient injected with what is suspected to be bellafill (b)(6) 2018 by an unknown provider.The exact injection date is unknown.The injections were off-label in the cheeks, chin, and jawline.On (b)(6) 2019, the patient's current provider reported the patient had nerve pain in the jaw caused by a granuloma pressing on a nerve.The current provider states the patient relayed she had a biopsy done that determined "a large granuloma of filler was pinching on the nerve" in the patient's jaw.The location and date of the biopsy is unknown.The granuloma was treated with intralesional kenalog injections and reduced in size, and the pain resolved (b)(6) 2019.Bellafill use is suspected, but cannot be confirmed.The dermal filler provider/injector is unknown.Bellafill 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.

Event Description

Patient injected with what is suspected to be bellafill (b)(6) 2018 by an unknown provider.The injections were off-label in the cheeks, chin, and jawline.On (b)(6) 2019, the patient's current provider reported the patient had nerve pain in the jaw caused by a granuloma pressing on a nerve.The granuloma was treated with intralesional kenalog injections and reduced in size.The pain resolved (b)(6) 2019.

• 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: 8677022
• MDR Text Key: 147305163
• Report Number: 3003707320-2019-00004
• Device Sequence Number: 1
• Product Code: LMH
• 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 Assistant
• Type of Report: Initial
• Report Date: 06/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/06/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: GBF0508 (SUSPECTED)
• Device Catalogue Number: GBF0508 (SUSPECTED)
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/07/2019
• 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): Required Intervention