MAUDE Adverse Event Report: TEOXANE SA RHA 4; HYALURONIC ACID DERMAL FILLER

Lot Number	TPUL-22251JL0, TPUL-23131BL0
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Granuloma (1876)
Date of Event	03/26/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
According to the information received, the nodules reported were confirmed as being granuloma.Granulomas that appear weeks to years after injection are known and widely documented reactions in the context of hyaluronic acid filler injections.They are caused by a delayed immune reaction in response to the filler, which is treated as a foreign body.Patient predisposition, trauma, vaccines, or infections are possible etiologies for this complication.Immune cells (macrophages) surround the product, inducing a destructive fibrotic process.Adequate treatment generally allows for a quick and effective resolution of these reactions, although certain granulomas at an advanced stage might be unresponsive to hyaluronidase.The risk of such reactions is mentioned in the instructions for use of rha 4 products.
Event or Problem Description
This case occurede outside of the usa, in italy.The italian subsidiary notified teoxane geneva of an adverse event on 24-apr-2024.A patient was injected with several teoxane products as follows:  - on (b)(6) 2023 with (current complaint) in the cheekbones (half of the vial on each side), - on (b)(6) 2023 with rha 3 (rc/2404123) in the nlf (half of the vial on each side), - on (b)(6) 2023 with puresense redensity 2 in the tear trough (half of the vial on each side), - on (b)(6) 2023 with rha 4 (current complaint) in the malar area (0.6 ml on each side).4 months after the last injection, on 26-mar-2024, the patient reported small nodules and slight swelling on the left side near the nose and the right side on the malar area.  2 weeks later, approximately on (b)(6) 2024, the swelling increased and was accompanied by redness in the same areas.The injector advised the patient to do an ultrasound.  on (b)(6) 2024, an ultrasound was done in belgium (the country of the patient) and confirmed the presence of granuloma.  as treatment, the patient took antibiotics (unknown type) and cortisone in (b)(6) 2024 (unknown exact date).The symptoms improved.The local medical expert was contacted to provide support in the case.On 29-apr-2024, we were informed that the patient was still taking antibiotics and cortisone.The symptoms were recovering.  on 16-may.2024, we were informed that the patient had a second ultrasound.No more signs of granuloma were observed, as well as no infection or inflammation.Only a few small, persistent deposits remained.  according to the local medical expert, the reaction had probably been triggered, but the patient did not mention anything.Thus, it was not possible to determine the cause of the granuloma.  according to the resolution of the symptoms, the case was closed.

• Brand Name: RHA 4
• Common Device Name: HYALURONIC ACID DERMAL FILLER
• Manufacturer (Section D): TEOXANE SA; rue de lyon 105; geneva, 1203 ; SZ 1203
• Manufacturer Contact: morgane burgisser
• MDR Report Key: 19379510
• Report Number: 3005975625-2024-00294
• Device Sequence Number: 18073764
• Product Code: LMH
• UDI-Device Identifier: 07640173232704
• UDI-Public: 01076401732327041022251JL01730062024
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: P170002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/23/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 06/30/2024
• Device Lot Number: TPUL-22251JL0, TPUL-23131BL0
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/24/2024
• Initial Report FDA Received Date: 05/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female