MAUDE Adverse Event Report: Teoxane SA RHA 3 Mepi; Hyaluronic Acid Dermal Filler Gel

Lot Number	25242GL0
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Inflammation (1932); Swelling/ Edema (4577); Implant site sclerosis (4903)
Date of Event	06/22/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Delayed inflammation event "[dermal filler reaction]" ("[skin induration]", "[skin oedema]").Case narrative: on 23-jun-2026, primevigilance notified teoxane geneva of an adverse event from the united states.According to the information received from the injector, a patient was injected on (b)(6) 2026 with rha 3 in the lips with a needle.The patient had a history of cold sores.In (b)(6) 2026 (unspecified date, reported as "recently"), the patient experienced a cold sore outbreak and was started on valtrex.The symptoms almost completely resolved.On (b)(6) 2026, the patient started to complain about swelling in her lips.The injector confirmed that the areas of filler were firm/hardened (photos provided) and believed that the cold sore outbreak triggered a delayed inflammation event.On (b)(6) 2026, the swelling worsened (photos provided).The patient was on medrol and received hyaluronidase (3 vials).Due to the severity of the event of swelling, the case was assessed as reportable.The outcome of the event was unknown.At the time of this report, no additional information was obtained regarding the outcome of the event.The evolution of the symptoms is being monitored.
Additional Manufacturer Narrative
Delayed inflammatory reactions that may manifest as swelling and induration 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 particular case, the injector confirmed that the cold sores were a potential trigger for the reaction.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 teoxane products.This is default text configured for block h10.

• Brand Name: RHA 3 Mepi
• Common Device Name: Hyaluronic Acid Dermal Filler Gel
• Manufacturer (Section D): Teoxane SA; rue de lyon 105; geneva 1203 ; SZ 1203
• Manufacturer (Section G): Teoxane SA; rue de lyon 105; geneva 1203 ; SZ 1203
• MDR Report Key: 25812730
• Report Number: 3005975625-2026-00044
• Device Sequence Number: 6038566
• Product Code: LMH
• UDI-Device Identifier: 07640173236177
• UDI-Public: (01)07640173236177(10)25242GL0(17)270614
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P170002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/13/2026

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 Lot Number: 25242GL0
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 06/23/2026
• Initial Report FDA Received Date: 07/14/2026
• Supplement Report FDA Received Date: 08/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/14/2025
• 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 Sex: Female