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

Model Number GBF0508

Device Problem Off-Label Use (1494)

Patient Problems Foreign Body Reaction (1868); Pain (1994); Nerve Proximity Nos (Not Otherwise Specified) (2647); Patient Problem/Medical Problem (2688)

Event Type  Injury  

Manufacturer Narrative

The patient ((b)(6)) was injected off-label in the hands with bellafill dermal filler (lot f151107) on (b)(6) 2015.Injector info: dr.(b)(6), md, (b)(6) on (b)(6) 2019, the patient reported nerve pain caused by a granuloma in her right hand that was "sitting on a nerve".On 08/15/2019, the patient's current provider, (b)(6) pac at (b)(6), indicates that to alleviate the nerve pain, treatment (cortisone injections) is required to shrink the nodule/suspected granuloma.Per the current provider a biopsy has not been done to confirm granuloma.Bellafill 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.Manufacturing records for lot f151107 were reviewed and no issues were noted.The lot was manufactured according to approved work instructions and met all acceptance criteria upon release.The lot has since expired (expiration date: 01/31/2017); therefore, retained lot samples were not available for review.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." nodules and/or granuloma 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

On (b)(6) 2019, the patient reported nerve pain caused by a granuloma in her right hand that was "sitting on a nerve".On 08/15/2019, the patient's current provider indicates that to alleviate the nerve pain, treatment (cortisone injections) is required to shrink the nodule/suspected granuloma.The patient had previously been injected with bellafill dermal filler off-label in the hands on (b)(6) 2015, by a different provider.

• 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: 8923683
• MDR Text Key: 158898509
• Report Number: 3003707320-2019-00014
• 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,other
• Reporter Occupation: Physician Assistant
• Type of Report: Initial
• Report Date: 08/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/22/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2017
• Device Model Number: GBF0508
• Device Catalogue Number: GBF0508
• Device Lot Number: F151107
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/23/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/14/2015
• 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