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

Lot Number	25232GL0
Medical Device Problem Codes	Off-Label Use (1494); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Codes	Pain (1994); Skin Discoloration (2074); Discomfort (2330); Foreign Body Embolism (4439)
Date of Event	04/27/2026
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.It also has to be noted that rha 2 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.
Event or Problem Description
Vascular occlusion "[vascular skin disorder]" ("[pallor]", "[livedo reticularis]", "[discomfort]", "[pain]") rha2 in the chin "[off label use]".Case narrative: on (b)(6) 2026, primevigilance notified teoxane geneva about an adverse event from the united states.According to the information received from the injector, a patient was injected on (b)(6) 2026 with 0.8 ml of rha 2 in the chin shadowing with a 30g needle.The day (on (b)(6) 2026), the patient noticed a blanching of the skin on palpation near the injection site and massaged the area.On (b)(6) 2026, the patient experienced tightness, pain and livedo reticularis (also reported by the patient as bruising).The injector prescribed the following treatments: massages applied warm compresses aspirin (325 mg) the same day, she also received hyaluronidase injections (hylenex, 2 vials) and felt slight relief.On (b)(6) 2026, the patient received again hyaluronidase injections (hylenex, 2 vials).She felt a lot better and the area was just sore and slightly tender.She applied a thin layer of nitro pace and was instructed to leave it on for at least six hours (nitro bid nitroglycerin ointment 2%).The patient¿s capillary refill returned to normal and the symptoms were monitored (photos provided).On (b)(6) 2026, the injector confirmed by ultrasound the vascular occlusion.The patient received hylenex and felt immediately relief of pain and discomfort.The patient was healing and was using skin care products to help the healing (more photos provided).We also received the information that the patient took: sildenafil (viagra, 50 mg), and antibiotics (doxycycline).At the stage the outcome of the events are resolving therefore the investigation is still ongoing.
Event or Problem Description
Vascular occlusion "[vascular skin disorder]" ("[pallor]", "[livedo reticularis]", "[discomfort]", "[pain]").Rha2 in the chin "[off label use]".Case narrative: on 30-apr-2026, primevigilance notified teoxane geneva about an adverse event from the united states.According to the information received from the injector, a patient was injected on (b)(6) 2026 with 0.8 ml of rha 2 in the chin shadowing with a 30g needle.The same day (on (b)(6) 2026), the patient noticed a blanching of the skin on palpation near the injection site and massaged the area.On (b)(6) 2026, the patient experienced tightness, pain and livedo reticularis (also reported by the patient as bruising).The injector prescribed the following treatments: - massages, - warm compresses, - aspirin (325 mg).The same day, she also received hyaluronidase injections (hylenex, 2 vials) leading to slight relief.On (b)(6) 2026, the patient received again hyaluronidase injections (hylenex, 2 vials).She felt a lot better and the area remained just sore and slightly tender.She applied a thin layer of nitro pace and was instructed to leave it on for at least six hours (nitro bid nitroglycerin ointment 2%).The patient¿s capillary refill returned to normal and the symptoms were monitored (photos provided).On (b)(6) 2026, the injector confirmed by ultrasound the vascular occlusion.The patient received hylenex and felt immediate relief from pain and discomfort.The patient was healing and was using skin care products to help the healing (more photos provided).We also received the information that the patient took: sildenafil (viagra, 50 mg), and antibiotics (doxycycline).The outcome of the event was resolving.Despite several reminders, no further information could be retrieved regarding the outcome of the event.Thus, the complaint was considered closed as is.
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.It also has to be noted that rha 2 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 2 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: 25316154
• Report Number: 3005975625-2026-00033
• Device Sequence Number: 5291771
• Product Code: LMH
• UDI-Device Identifier: 07640173233527
• UDI-Public: (01)07640173233527(10)25232GL0(17)20270607
• 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,Followup
• Report Date (Section B): 06/26/2026

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: 25232GL0
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/28/2026
• Supplement Report FDA Received Date: 06/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/07/2025
• 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 Age: 33 YR
• Patient Sex: Female