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 in one of the locations injected with bellafill in acne scars on the cheeks. The patient was treated with antibiotics. 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 04/21/2020 and 04/22/2020, 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. Timeline: initial report on 04/21/2020: per the injector, the patient was injected in several acne scars on the cheeks at the same time in (b)(6) 2019. Only one (1) of those scars presented with signs of infection (hardness, swelling, redness, and drainage at the injection site). The patient was improving on antibiotics. 04/22/2020: the doctor relayed that they feel this was an infection secondary to the injection procedure and not the bellafill, per se. 07/22/2020: additional information was requested from the account, including current patient status and lot numbers. 07/29/2020: no response from the account. A reminder was sent for the requested additional information. 07/30/2020: shipping history has been reviewed to determine potential bellafill lots based on the doctor-relayed injection timeframe of (b)(6) 2019. A follow up mdr will be filed once any updates are received. The bellafill lot used in the patient's procedure is unknown and bellafill use cannot be confirmed at this time. Shipping history has been reviewed to determine potential bellafill lots based on the doctor-relayed injection timeframe of (b)(6) 2019. Fda will be informed of the results of the reviews of the potential bellafill lots. 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, artefill (now bellafill) injection carries a risk of infection. The usual precautions associated with injectable materials should be followed. " 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 in one of the locations injected with bellafill in acne scars on the cheeks. The patient was treated with antibiotics. 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: 10353924
• MDR Text Key: 207818152
• Report Number: 3003707320-2020-00007
• 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

• Type of Report: Initial,Followup
• Report Date: 07/31/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/31/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Model Number: GBF0508 (SUSPECTED)
• Device Catalogue Number: GBF0508 (SUSPECTED)
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 04/21/2020
• 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 Treatment Data

Date Received: 07/31/2020 Patient Sequence Number: 1