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

Lot Number	24042AL0
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Granuloma (1876)
Date of Event	03/15/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.When it comes to the malar area, the malar septum is thought to be a relatively impermeable barrier that allows tissue edema to accumulate above its cutaneous insertion due to compromised lymphatic drainage.The risk of such reactions is mentioned in the instructions for use of teoxane products.
Event or Problem Description
This case occured outside of the usa in poland.The polish subsidiary notified teoxane geneva of an adverse event on 07-apr-2025.During teoxane workshop in poland on (b)(6) 2024, a female patient was injected with the following products: 0.1 ml of rha 1 in the tear trough, using the needle provided in the box (current complaint).1.2 ml of rha 4 in the cheeks, using a 22g/50mm cannula (rc/2504041).2.4 ml of ultra deep in the cheeks, using a 22g/50mm cannula (rc/2504042).On an unknown date after the injection, the patient experienced swelling in the right tear trough, where teosyal rha 1 was injected.In 2025, the local medical expert was contacted and followed up the patient.According to the information received on 06-jun-2025, the medical expert received the patient for consultation on (b)(6) 2025 and confirmed the presence of palpable, hard, immobile, lumpy lesions located in the central part of the face.The symptoms started around on (b)(6) 2025.In the left zygomatic and in temporal region, some massive, cohesive, hard subcutaneous lesions, immobile relative to the surrounding tissues were also observed.No other symptoms were reported.An ultrasound was performed the same day confirming the presence of numerous hypoechoic nodules also reported as painless granulomatous lesions.According to the diagnosis provided by the medical expert this case was assessed as reportable.The patient was injected with 800 ui of hyaluronidase and received led radiation during 15 minutes.He was also prescribed the following treatments: antibiotics (augmentin 2×1g and klacid 2×500 mg.Glucocorticoids (encorton 2×40 mg) for 3 days, then reduction of the dose by 10 mg every 3 days probiotic.According to the information received on 11-jun-2025, the patient was fine and the problem resolved, therefore the case was closed.

• Brand Name: RHA REDENSITY
• 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
• MDR Report Key: 22235064
• Report Number: 3005975625-2025-00053
• Device Sequence Number: 13048223
• Product Code: LMH
• UDI-Device Identifier: 07640173233763
• UDI-Public: 01076401732337631024042AL017260130
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• PMA/510(K) Number: P170002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• 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): 06/17/2025

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: 01/30/2026
• Device Lot Number: 24042AL0
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/06/2025
• Initial Report FDA Received Date: 06/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/01/2023
• 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; Required Intervention
• Patient Age: 42 YR
• Patient Sex: Female