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

Model Number AF0508

Device Problem Use of Device Problem (1670)

Patient Problems Granuloma (1876); Patient Problem/Medical Problem (2688)

Event Date 07/08/2008

Event Type  Injury  

Manufacturer Narrative

Suneva medical is filing this emdr from a conservative standpoint based on a medwatch filed recently by the patient (medwatch mw5077470).On 06/11/2018, suneva complaint department received medwatch mw5077470.Patient indicates "serious injury" under event report type and "disability/permanent damage" under event outcome, implying that artefill injected around her mouth has permanently changed the way her lips move.More details can be found on mw5077470.The patient had previously reported lumps/bumps around the mouth to suneva medical on (b)(6) 2018.The patient also relayed some stiffness around the mouth; however there was no indication that the stiffness was disability/permanent damage.Information provided by the injector (dr.(b)(6)) indicated they last saw the patient in 2009 after her injections.Patient would not provide information related to any current doctor, but would not go back to see her injector.The patient indicated she saw her injector in 2014.Dr.(b)(6) office did not indicate any patient visit after 2009.It was relayed to the patient that, if she is not seeing dr.(b)(6), she choose another physician to determine/diagnose her current issues.The injector's office provided two lot numbers used in the patient's procedure on (b)(6) 2008: lot f081006, model af0508, expiration date: 01/31/2009; manufacture date: 02/27/2008.Lot f081030, model af0504, expiration date: 12/31/2008; manufacture date: 04/11/2008.The manufacturing records for both lots were reviewed with no issues noted.Both lots have since expired; therefore retained lot samples were unavailable for review.Per her injector (dr.(b)(6) office) the patient was injected in both on-label (nasolabial folds) and off-label (marionette lines) locations.At the time of the injection, artefill (now known as bellafill) was indicated for the nasolabial folds.Injector information: (b)(6).

Event Description

Patient, via medwatch mw5077470, indicates "serious injury," implying that artefill injected around her mouth has permanently changed the way her lips move.Patient was injected in both on-label (nasolabial folds aka smile lines) and off-label (marionette lines) areas.

• Brand Name: ARTEFILL 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: 7680151
• MDR Text Key: 113741355
• Report Number: 3003707320-2018-00012
• 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: 07/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/11/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 01/31/2009
• Device Model Number: AF0508
• Device Catalogue Number: AF0508
• Device Lot Number: F081006
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/11/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/27/2008
• 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): Disability