MAUDE Adverse Event Report: TEOXANE SA RHA 2; HYALURONIC ACID DERMAL FILLER

Lot Number	23252GL0
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Swelling/ Edema (4577)
Date of Event	04/24/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
On 23-may-2025, the italian subsidiary notified teoxane geneva of an adverse event.A patient was injected on (b)(6) 2024 with 0,5 ml of rha 2 in the lips using the retrotracing technique and the needle provided in the box (30g/13mm).The patient had an history of previous aesthetic procedure in the lips: on (b)(6) 2023: teosyal rha 3 (given the injection date, no other complaint was opened for this teoxane product).According to the information received, on (b)(6) 2025, the patient experienced an episode of viral infection (with fever and vomiting) and the next day she started to have swelling and oedema in her lips.Due to the severity of the symptoms, this case was assessed reportable.She went to emergency room where she was prescribed corticoids (bentelan 1 mg) and antihistamine treatment (zirtec) for 5 days and the symptoms disappeared.On (b)(6) 2025 in the evening a strong oedema appeared again in the same area.A second course of corticoids (cortisone) was prescribed and the symptoms improved but returned after the stopping the treatment and a third course of corticoids was prescribed (bentelan to scaling the dose: 2 mg, 2 mg, 2 mg, 1 mg and 1 mg for 5 days).On (b)(6) 2025, we were informed that the symptoms disappeared and the case was closed.
Additional Manufacturer Narrative
Delayed inflammatory reactions that may manifest as oedema weeks to years after injection are well-known and documented reactions in the context of hyaluronic acid dermal filler injections.They may be related to a delayed immune response or to a bacterial infection.They can be triggered by patient predisposition, trauma, vaccines, or infections (in this case a viral infection).With medical treatment, symptoms can be quickly fully resolved, without sequelae.In addition, the risk of such reactions is mentioned in the instructions for use of products.

• Brand Name: RHA 2
• Common Device Name: HYALURONIC ACID DERMAL FILLER
• Manufacturer (Section D): TEOXANE SA; rue de lyon 105; geneva, 1203 ; SZ 1203
• Manufacturer Contact: anaïs moreau
• MDR Report Key: 22149605
• Report Number: 3005975625-2025-00045
• Device Sequence Number: 7849769
• Product Code: LMH
• UDI-Device Identifier: 07640173230045
• UDI-Public: 010764017323004510023252GL017250630
• 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: 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): 06/05/2025

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: 06/30/2025
• Device Lot Number: 23252GL0
• 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: 05/23/2025
• Initial Report FDA Received Date: 06/05/2025
• 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; Required Intervention
• Patient Age: 26 YR
• Patient Sex: Female