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

Model Number GBF0508 (SUSPECTED)

Device Problem Insufficient Information (3190)

Patient Problems Foreign Body Reaction (1868); Pain (1994); Swelling (2091); Patient Problem/Medical Problem (2688)

Event Date 06/06/2019

Event Type  Injury  

Manufacturer Narrative

Patient-filed medwatch mw5087426: event report type: serious injury; report date: 13-jun-2019;.Description: "i had bellafill over a year ago with no issues.Out of the blue my face swelled up, the areas where bellafill was became rock hard and tender to touch.It felt like my skin was going to rip.I now look disfigured.I ended up going to emergency room." no other information was provided.No contact information.Lot number and injector are unknown.Locations of injections and/or bellafill use cannot be confirmed.Whether medical intervention was required or not is unknown.Suneva could not find this same complaint in their complaint history and are proving this mdr based on the patient's statements in mw5087426 indicating serious injury, permanent injury is implied ("disfigured"), and initial hospitalization (emergency room).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." swelling, nodules, and pain 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

Patient-filed medwatch mw5087426; event report type: serious injury; report date: 13-jun-2019; description: "i had bellafill over a year ago with no issues.Out of the blue my face swelled up, the areas where bellafill was became rock hard and tender to touch.It felt like my skin was going to rip.I now look disfigured.I ended up going to emergency room." no contact or other information was provided.

• 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: 8876711
• MDR Text Key: 153983459
• Report Number: 3003707320-2019-00012
• 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: 08/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/08/2019
• 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
• Date Manufacturer Received: 07/09/2019
• 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): Hospitalization; Disability