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

Lot Number	2403R2L0
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Skin Infection (4544)
Date of Event	12/13/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
According to the information received the case seems to be linked to a phlegmon.Delayed skin infections that appear weeks to years after injection are well-known and documented adverse reactions to hyaluronic acid filler injections.They occur when injected filler material becomes contaminated with bacteria.This process gives rise to a permanent low-grade chronic infection, and it may eventually lead to a chronic granulomatous reaction.Given the sterility of the gel, they are rather due to a lack of asepsis during injection and/or posttreatment care.It can also occur by reactivating a previously quiescent biofilm that formed after a previous filler treatment or after a bacteremia.Appropriate treatment allows progressive resolution of the symptoms.The risk of such reactions is mentioned in the instructions for use of products.
Event or Problem Description
This case occured outside of the usa in australia.On (b)(6)2024, the australian subsidiary notified teoxane geneva of an adverse event.According to the information received, a patient was injected on (b)(6)2024 with the following products: - 1.2 ml of rha 4 in both cheeks using a 25 g cannula and retrotracing technique (current complaint).- 1.2 ml of ultra deep in both cheeks using the needle supplied in the box and the bolus technique (b)(6).Approximately 5 months after the injections, on (b)(6)2024, the patient experienced a lump/nodule of 1-1.5 cm in diameter of moderate intensity in the right cheek and informed the clinic owner about the event she was considering as a potential late onset reaction on (b)(6)2024.The patient was advised to wait and got an appointment with the injector (nurse) and a doctor on (b)(6)2024.During the appointment the patient presented a nodule on the right cheek, a swelling extended under the right eye, and pain and pushing of the lump after the assessment.The patient also complained about the size of the nodule that was increasing with time.During the appointment, obvious asymmetry in the cheeks was also observed.During the appointment, the patient explained to the injector that she had a history of cellulitis for the past 3 years at the elbow (3 times) and knee (2 times).A dissolution with hyalase was proposed if allergic testing were performed, and in the meantime, the patient was prescribed high-dose steroid treatment (prednisolone 50 mg) for 3 days starting on(b)(6)2024.On (b)(6)2024, the patient visited a gp who extended the steroid treatment for 3 additional days, prescribed antibiotic treatment (flucloxacilin 500 mg x7 tablets) and an ultrasound exam was performed (report not available).On (b)(6)2024, an appointment was scheduled with the injector, but it was cancelled by the patient.On (b)(6)2024, the symptoms worsened, and the patient went to the emergency department.She complained about chronic swelling, no heat, and no pain.Blood testing and another ultrasound exam were performed.They diagnosed the lump as a phlegmon, gave the patient stronger antibiotics (augmentin duo forte) for 5 days, and told her that if after 5 days it was no better, she would have to see a facial surgeon to get it cut out.The patient also stated that "infection introduced from needle site.".According to the diagnosis, this case was then considered serious and reportable on (b)(6)2025.According to the information received on (b)(6)2025, the nodule was worsening despite the steroid and antibiotic treatments, and a new nodule appeared in the left cheek.Hyalase was injected on (b)(6)2025 and the nodules decreased in size.At the time of this report, no additional information was retrieved.The patient is following up by the injector.

• Brand Name: RHA 4
• Common Device Name: HYALURONIC ACID DERMAL FILLER
• Manufacturer (Section D): TEOXANE SA; rue de lyon 5; geneve, 1203 ; AS 1203
• Manufacturer Contact: céline vial
• MDR Report Key: 21262146
• Report Number: 3005975625-2025-00001
• Device Sequence Number: 4276653
• Product Code: LMH
• UDI-Device Identifier: 07640173232704
• UDI-Public: 0107640173232704102403R2L017251230
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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): 01/27/2025

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: 12/30/2025
• Device Lot Number: 2403R2L0
• 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: 12/24/2024
• Initial Report FDA Received Date: 01/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/30/2023
• 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 Sex: Female