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

Lot Number	23152EL0
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Granuloma (1876)
Date of Event	02/22/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Tis case occured outside of usa in portugal.On (b)(6) 2025, the spanish/portuguese subsidiary notified teoxane geneva about an adverse event occurring in portugal.According to the information received, the patient was injected on (b)(6) 2023 with 1.2 ml of rha 4 in the cheeks and she received harmonyca lidocaine treatment the same day in the perioral area.On (b)(6) 2025 the patient had a dental implant and received an anti-inflammatory treatment on the following day started on (b)(6) 2025.Approximately one week later, on (b)(6) 2025, the patient experienced oedema, erythema and induration in malar area on the left side.Approximately 2 weeks later, on (b)(6) 2025, the patient experienced the same symptoms on the right side and was prescribed antibiotic treatment (amoxicillin/clavulanic acid 875 mg/125 mg).12 days later, on (b)(6) 2025, a granulomatous reaction in the buccal area was diagnosed with anatomo-pathological examination and the patient was prescribed glucocorticoids (prednisolone).Considering the diagnosis, this case was assessed as serious and reportable.Additionally, the patient was taking several medications for undefined rheumatic disease.On (b)(6) 2025 all symptoms almost subsided.According to the information received on (b)(6) 2025, the reporter who was not the injector assessed the reaction as being due to harmonyca lidocaine treatment.Despite several reminders, no further information was retrieved therefore, considering also the good evolution of the symptoms, the case was closed as this.
Additional Manufacturer Narrative
Granulomas, potentially triggered by a dental implant, 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.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 products.

• Brand Name: RHA 4
• Common Device Name: HYALURONIC ACID DERMAL FILLER GEL
• Manufacturer (Section D): TEOXANE SA; rue de lyon 105; geneva, 1203 ; SZ 1203
• Manufacturer Contact: celine vial ; SZ
• MDR Report Key: 21854037
• Report Number: 3005975625-2025-00024
• Device Sequence Number: 12922313
• Product Code: LMH
• UDI-Device Identifier: 07640173232704
• UDI-Public: 01076401732327041023152EL017250430
• Combination Product (Y/N): Y
• Initial Reporter Country: PO
• 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): 03/20/2025

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: 04/30/2025
• Device Lot Number: 23152EL0
• 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: 03/20/2025
• Initial Report FDA Received Date: 04/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/30/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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 Age: 73 YR
• Patient Sex: Female