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

Lot Number	25212CL0
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Codes	Local Reaction (2035); Skin Discoloration (2074); Foreign Body Embolism (4439)
Date of Event	05/02/2026
Type of Reportable Event	Serious Injury
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.Local reactions that may manifest as early bleeding after injection are well-known and documented adverse reactions to hyaluronic acid filler injections.These reactions are related to the traumatic environment of the injection, vary according to injection volume and technique and patient factors, and are usually resolved spontaneously.Moreover, the risk of such reactions is mentioned in the instructions for use of teoxane products.In this particular case, the patient also experienced bruising due to hyaluronidase injection.In this particular case, the patient also experienced bruising due to hyaluronidase injection.This is default text configured for block h10.
Event or Problem Description
Suspicion of vascular occlusion/5-6 second capillary refill [vascular skin disorder] ([pallor]).Client tolerated injections well/minimal bleeding noted [injection site haemorrhage].Minimal bruising - hyalaze injected into upper lip [injection site haemorrhage].Case narrative: on 05-may-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 0.6 ml of rha 3 in the upper and bottom lips with the "russian" injection technique.The patient did not have any significant medical history or known drug allergies.Several years ago she had a wisdom teeth removal.Patient's concomitant medication included zepbound, fluoxetine and buspirone.On (b)(6) 2026, after the injection, the patient experienced minimal bleeding.She had arnica gel applied and tolerated well the injections.On (b)(6) 2026,in the morning, the patient experienced a small white area and cam back to the injector (nurse) facility for a suspicion of vascular occlusion.The later noted a small area on the left upper lip that was white with 5-6 second capillary refill.Patient denied pain and instant capillary refill was noted throughout the rest of the lip and mouth area.Due to high suspicion of vascular occlusion, the nurse dissolved entire upper lips following vascular occlusion protocol (hyalaze (hyaluronidase) 1500 iu reconstituted with 2 ml) with an insulin needle.The nurse massaged the lips and applied warm compress.Upon dissolution, instant capillary refill was noted throughout area of concern and instant capillary refill was maintained throughout all lip and surrounding tissue.The patient tolerated the dissolution well with only minimal bruising noted to left upper lip.She got instructions to monitor the capillary refill at home and to send regular pictures.On (b)(6) 2026, the patient had a follow-up appointment at which instant capillary refill was noted throughout all lip tissue and surrounding areas.The patient denied pain and any visual changes.There was minimal bruising to left upper lip but was healing very well.The patient was scheduled to reinject the upper lip with filler in 4 weeks.The outcome of the vascular event was resolved.The complaint was considered closed.

• 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: 25348462
• Report Number: 3005975625-2026-00034
• Device Sequence Number: 18829116
• Product Code: LMH
• UDI-Device Identifier: 07640173236177
• UDI-Public: (01)07640173236177(10)25212CL0(17)270520
• 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): 06/01/2026

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: 25212CL0
• 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: 06/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/20/2025
• 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