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

Lot Number	2409R1L0
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Cellulitis (1768)
Date of Event	01/30/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Skin infections such as cellulitis, appear within days after injection.These are well-known and widely documented adverse reactions in the context of hyaluronic acid filler injections.Infections are usually caused by an association of multiple bacteria that invade the wound at the site of injection due to a temporary disruption of the skin barrier.Lack of asepsis during injection and/or posttreatment care and intraoral injections are common etiologies for this complication.Adequate treatment with antibiotics leads to a complete resolution of the symptoms without sequelae.Additionally, the risk of such adverse events is mentioned in the instructions for use of products.
Event or Problem Description
This case occured outside of the usa in spain.On (b)(6)2025, the spanish subsidiary informed teoxane geneva about an adverse event.According to the information received, a patient was injected on (b)(6)2024 with the following products: - 2.4 ml of puresense ultra deep: 1.2ml in cheeks, cheekbones and chin and 1.2 ml in the jawlines (rc/2502020).- 4.4 ml of rha 4: 0.8 ml in the cheeks, 1.2 ml in cheekbones, 1.2 ml in marionette lines and 1.2 ml in jawline/mandibula (current complaint).The patient had history of previous injections of hyaluronic acid (unspecified), of biostimulator (radiesse), botox and carboxytherapy in the past (undefined dates) and experienced granolumas due to radiesse product.She also had a dental treatment on (b)(6)2025 and was taking colagen and vitamins as medications during the injection.Approximately 2,5 months after the injection, on (b)(6)2025, the patient experienced skin induration and erythema in the peri orbital area, diagnosed as cellulitis of moderate intensity.One day after, on (b)(6)2025, the patient experienced nodules of moderate intensity in the mandibula and in the chin.The patient was prescribed the following treatments on (b)(6)2025: - 3 different antibiotics (amoxilin 875/clavulanic acid and clarithromycin 500 and moxifloxacin 400) for 4 days - 1 anti inflammatory treatment (dacortin) for 4 days.On (b)(6)2025, the symptoms were improving.According to the information received on 03-mar-2025, the patient received in total 5 sessions of hyaluronidase with a decreasing dose.The symptoms were evolving well and the patient was followed up closely by the injector.Considering the evolution of symptoms and the last patient's monitoring with the injector, this case was considered as 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
• MDR Report Key: 21512779
• Report Number: 3005975625-2025-00005
• Device Sequence Number: 15444385
• Product Code: LMH
• UDI-Device Identifier: 07640173230069
• UDI-Public: 0107640173230069102409R1L017260228
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• 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): 03/04/2025

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: 02/28/2026
• Device Lot Number: 2409R1L0
• 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: 02/07/2025
• Initial Report FDA Received Date: 03/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/28/2024
• 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: 58 YR
• Patient Sex: Female