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

Lot Number	24352BL0
Medical Device Problem Codes	Off-Label Use (1494); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Codes	Hypersensitivity/Allergic reaction (1907); Foreign Body Embolism (4439); Swelling/ Edema (4577)
Date of Event	04/24/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Vascular occlusion [vascular skin disorder] histamine response after treatment [type i hypersensitivity] ([skin oedema]) rha3 in chin [off label use].Case narrative: on 28-apr-2026, primevigilance notified teoxane geneva of an adverse event from the united states.According to the information received from a health care professional, a patient was injected on (b)(6) 2026 with rha 3 mepi in the chin, nasolabial folds, and lips (no further information).On (b)(6) 2026, immediately after treatment, the patient experienced a histamine response with swelling of the injected areas but also a swelling of the eyes and the neck.These events were resolved without treatment.The patient had also experienced a vascular occlusion; the filler was dissolved and the symptoms resolved.Due to the seriousness of the event, the case was assessed as reportable.Considering the resolution of the symptoms, the complaint was considered closed.Imdrf code annex g is erroneous is this case (due to database issue).Please consider code g04127 ¿ syringe (fda 987).
Additional Manufacturer Narrative
Vascular complications are rare and serious side effects, although they are widely known and documented in the context of dermal filler injections.They are related to the accidental injection of the product inside a blood vessel, leading to its occlusion, or to a high amount of product injected near a vessel, leading to its compression.The local deprivation of blood supply causes tissue anoxia.If enough hyaluronidase is injected on time, symptoms can be fully resolved without sequalae.If the vascular complication is not detected, diagnosed, and treated promptly, it can lead to skin necrosis.The risk of such adverse reactions is mentioned in the instructions for use of teoxane products.Allergic reactions that may manifest as swelling within minutes to hours are well-known and documented adverse reactions to hyaluronic acid filler injections.They are immune-mediated reactions related to patient conditions such as allergies to ha, lidocaine, or nickel composing the needle.With medical treatment, symptoms can be fully resolved quickly and without sequelae.In addition, the risk of such reactions is mentioned in the instructions for use of teoxane products.It also has to be noted that rha 3 is not indicated for the chin.Therefore, this constitutes an off-label use for which the safety and performance of the product cannot be guaranteed.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: 25313827
• Report Number: 3005975625-2026-00032
• Device Sequence Number: 21468168
• Product Code: LMH
• UDI-Device Identifier: 07640173236177
• UDI-Public: (01)07640173236177(10)24352BL0(17)260826
• 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
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/28/2026

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 Expiration Date: 08/26/2026
• Device Lot Number: 24352BL0
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/26/2024
• 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