MAUDE Adverse Event Report: TEOXANE SA RHA 3; HYALURONIC ACID DERMAL FILLER

Lot Number	23191FL0
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Neuralgia (4413)
Date of Event	06/16/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
According to the information received, the case is linked to a trigeminal neuralgia.Nerve compressions are rare but known adverse reactions following hyaluronic acid-based dermal filler injections.Indeed, cases of inadvertent nerve damage following dermal filler procedures have been reported in the literature.Several causes have been hypothesized: direct nerve damage by the needle during injection, injection of filler into the nerve, or tissue compression (by the product or by tissue swelling following the procedure).In turn, this can induce pain and other complications, such as a transient loss of sensitivity in the affected areas.A quick treatment with hyaluronidase sessions leads to a quick resolution without sequelae.Additionally, the recommendation to not inject close to a nerve and avoid damaging a nerve is mentioned in the instructions for use of this product.
Event or Problem Description
This case occured outside of the usa in australia.On 12-feb-2025, the australia subsidiary notified us of an adverse event.According to the information received, a patient was injected on (b)(6) 2024 with 1 ml of rha 3 in jowl and in marionette lines with a cannula (steriglide 0.50x38mm/25g) using the fanning technique.Approximately 3 weeks after the injection the patient experienced severe pain starting from lateral cheek to all the mid-face on the right side and several months later a severe trigeminal neuralgia was diagnosed by a neurologist.Considering the severity of the event and the diagnosis, the case was assessed as reportable.On (b)(6) 2025, a medical assistance was provided and differential etiologies of the reaction were explained.The medical expert confirmed a possible contribution of ha filler injections to trigeminal neuralgia-like symptoms weeks later through several potential mechanisms.According to the information received on 05-mar-2025, the injector never answered to the medical expert, neither the subsidiary and no more information was retrieved.Therefore the case was closed as this.

• Brand Name: RHA 3
• Common Device Name: HYALURONIC ACID DERMAL FILLER
• Manufacturer (Section D): TEOXANE SA; rue de lyon 105; geneva, 1203 ; SZ 1203
• Manufacturer Contact: céline vial
• MDR Report Key: 21595283
• Report Number: 3005975625-2025-00011
• Device Sequence Number: 15688153
• Product Code: LMH
• UDI-Device Identifier: 07640173230045
• UDI-Public: 01076401732300451023191FL017250531
• 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): 02/12/2025

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: 05/31/2025
• Device Lot Number: 23191FL0
• 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: 02/12/2025
• Initial Report FDA Received Date: 03/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/31/2023
• 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