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

Model Number GBF0508 (SUSPECTED)

Device Problem Use of Device Problem (1670)

Patient Problems Unspecified Infection (1930); Patient Problem/Medical Problem (2688)

Event Type  Injury  

Manufacturer Narrative

Doctor reports infection with a patient that was injected with bellafill by another doctor off-label on the cheeks.The patient was treated with antibiotics.Bellafill use has not been confirmed.It is unknown at this time if medical intervention was required to prevent permanent impairment or damage.Rationale for delayed submission of this mdr: at the time of report receipt on 06/09/2020, suneva had determined that an mdr was not required; however subsequent review found that a conservative mdr was warranted, as it is unknown at this time if medical intervention was required to prevent permanent impairment or damage, however it is implied.Timeline: initial report on 06/09/2020: sales rep relayed that dr.(b)(6) (not the injector) has a patient who says she had an infection from bellafill.06/10/2020: the doctor relayed that the patient was injected in multiple areas and one area on the cheek developed an infection.The patient had been treated with antibiotics and drainage from the area, and the infection had settled.The patient was now presenting with a firm nodule in the same area.07/24/2020: additional information was requested from the account, including current patient status and name of the facility where the patient was injected.08/03/2020: no response from the account.A reminder was sent for the requested additional information.A follow up mdr will be filed once any updates are received.The bellafill injector is unknown.The bellafill lot used in the patient's procedure is unknown.Bellafill use cannot be confirmed at this time.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.The bellafill ifu contains the following precaution: "as with all transcutaneous procedures, bellafill injection carries a risk of infection.The usual precautions associated with injectable materials should be followed." nodules are anticipated patient events that are documented in the bellafill ifu.Clinical studies support that nodules may resolve over time with or without treatment.Bellafill syringes are single use devices and are typically discarded after use.Per the bellafill ifu: "the syringe and any unused material should be discarded after a single treatment visit.".

Event Description

Doctor reports infection with a patient that was injected with bellafill by another doctor off-label in the cheeks.The patient was treated with antibiotics.Bellafill use has not been confirmed.It is unknown at this time if medical intervention was required to prevent permanent impairment or damage.

• 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
• Manufacturer (Section G): SUNEVA MEDICAL, INC.; 5870 pacific center blvd.; san diego, ca
• Manufacturer Contact: stacy lewis ; 5870 pacific center blvd.; san diego, ca ; 7685492
• MDR Report Key: 10358193
• MDR Text Key: 203290716
• Report Number: 3003707320-2020-00008
• 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: 08/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/03/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: GBF0508 (SUSPECTED)
• Device Catalogue Number: GBF0508 (SUSPECTED)
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/09/2020
• 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