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

Model Number GBF0508

Device Problem Off-Label Use (1494)

Patient Problems Foreign Body Reaction (1868); Patient Problem/Medical Problem (2688)

Event Type  Injury  

Manufacturer Narrative

Per the reporter, medical intervention (surgery) is primarily required to resolve a large lump that developed after off-label bellafill dermal filler injection in the jawline.As of this submission, it is unknown if the surgery has been done yet; however it is planned along with an expected facelift revision.The bellafill injection occurred in (b)(6) 2017.An exact date was not provided.The patient was injected on the same day off-label in the bilateral jawline, both cheeks, and both temples.No issues were reported in the other areas injected.The lump is on one side of the jawline.An exact date for onset of the lump was not provided, but is suspected to be b)(6) 2019.Suneva conducted a review of the lot used in the patient's procedure, lot f161091.No issues were found.The lot was manufactured according to approved work instructions and met all acceptance criteria upon release.The lot expired on 11/24/2017; therefore, retained lot samples were not available for review.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.Lumps 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 (surgery) required to resolve a large lump on the jawline that developed after bellafill dermal filler injection.

• 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: 9130796
• MDR Text Key: 165760110
• Report Number: 3003707320-2019-00017
• 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: Nurse
• Type of Report: Initial
• Report Date: 09/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/27/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/24/2017
• Device Model Number: GBF0508
• Device Catalogue Number: GBF0508
• Device Lot Number: F161091
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/29/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/12/2016
• 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