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

Model Number GBF0508

Device Problems Improper or Incorrect Procedure or Method (2017); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Foreign Body Reaction (1868)

Event Date 09/01/2016

Event Type  Injury  

Manufacturer Narrative

The patient was injected with the product on two different occasions in the same areas: the most recent was with bellafill dermal filler ((b)(4)), lot f151077, in (b)(6) 2015 (exact date unknown).The prior injection was with artefill dermal filler ((b)(4), artefill is the prior brand name), lot f141032, on (b)(6) 2015.Suneva conducted a lot review of a both lots.No issues were found with either lot.The lots were manufactured in accordance with approved work instructions and met acceptance criteria at time of product release.Retained lot samples were also reviewed and the lots continue to meet release criteria.The doctor originally reported nodules on (b)(6) 2016 which were being successfully treated with kenalog, 5fu, and collagenase.The "wood tissue changes" were added by the doctor on (b)(6) 2017.On (b)(6) 2017, the doctor relayed that the "woody tissue changes" were disfiguring and were only improving with multiple treatment injections.The patient was injected in both on-label and off-label locations and had nodules in all areas; however it is not clear at this time where the described "woody tissue changes" were located: on-label: nasolabial folds; off-label: brow, peri-oral areas, and under the eyes.The bellafill injector is aware of bellafill indications.

Event Description

Patient ((b)(6)) was injected with bellafill dermal filler (and artefill dermal filler - prior brand name) in the brows, nasolabial folds, peri-oral area, and under the eyes on (b)(6) 2015 and in (b)(6) 2015 (exact date not provided).On (b)(6) 2017 the doctor reported what he described as "woody tissue changes." on (b)(6) 2017, the doctor added that the "woody tissue changes" are disfiguring and are only improving with multiple "dissolving" injections of kenalog, 5fu, and collagenase.

• 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 ; 8585509999
• MDR Report Key: 6375143
• MDR Text Key: 68967995
• Report Number: 3003707320-2017-00006
• 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: 03/22/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/02/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 11/26/2016
• Device Model Number: GBF0508
• Device Catalogue Number: GBF0508
• Device Lot Number: F151077
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/03/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/30/2015
• 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
• Treatment: ARTEFILL DERMAL FILLER
• Patient Outcome(s): Required Intervention