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 Foreign Body Reaction (1868); Tissue Damage (2104); Patient Problem/Medical Problem (2688)

Event Type  Injury  

Manufacturer Narrative

Patient with deformity (divot) in the right lateral brow and temporal area following off-label filler injection in the temples, subsequently developing granuloma, and treatment with kenalog causing atrophy.Treatment (excision of granuloma and injection of h.A.Filler to address the divot) was required to resolve.Granuloma was confirmed via biopsy.Excision of granuloma occurred (b)(6) 2019.Date of subsequent h.A.Filler injection is unknown, but is suspected to be in (b)(6) or (b)(6) 2019.The reporter and doctor who performed excision and subsequent h.A.Filler injection (dr.(b)(6)) was not the bellafill dermal filler injector.The bellafill injector also injected the granuloma with kenalog which led to the atrophy.The name of the bellafill injector is unknown; therefore suneva is unable to determine potential bellafill lot number via shipping history.Bellafill dermal filler 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." 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.Granuloma are anticipated patient events that are documented in the bellafill instructions for use.Clinical studies support that these issues may resolve over time with or without treatment.

Event Description

Medical intervention required.Patient with deformity (divot) in the right lateral brow and temporal area following off-label filler injection in the temples and subsequently developing granuloma that was treated with kenalog causing atrophy.Treatment (excision of granuloma and injection of h.A.Filler to address the divot) was required, per treating doctor.

• 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: 9213890
• MDR Text Key: 163147440
• Report Number: 3003707320-2019-00019
• 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
• Type of Report: Initial
• Report Date: 10/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/21/2019
• 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: 09/20/2019
• 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
• Patient Age: 45 YR