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

Model Number GBF0508 (SUSPECTED)

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); Swelling (2091); Patient Problem/Medical Problem (2688)

Event Date 12/31/2015

Event Type  Injury  

Manufacturer Narrative

On 06/05/2018, suneva complaint department received medwatch mw5077411.Patient indicates "serious injury" under event report type, indicating reoccurring pain and swelling, as well as "growth" of the implant.Patient also indicates that a facelift will be required to resolve the issue.More details can be found on mw5077411.No other information was provided after multiple attempts to reach the patient with the phone number and email address noted on the medwatch form.Lot number and injector are unknown.Location of injections and/or bellafill use cannot be confirmed.Suneva could not find this same complaint in their complaint history and so are providing this mdr based on the patient statement in mw5077411 and selection of "serious injury" under event report type.Additional info regarding in this emdr report: similar terms to "growth" of the implant could not be found.(b)(4).

Event Description

Patient, via medwatch mw5077411, indicates "serious injury," relaying reoccurring pain and swelling, as well as growth of the implant.Patient also implies that a facelift will be required to resolve.

• 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: 7665213
• MDR Text Key: 113283039
• Report Number: 3003707320-2018-00011
• 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: 07/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/05/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: GBF0508 (SUSPECTED)
• Device Catalogue Number: GBF0508 (SUSPECTED)
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/05/2018
• 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