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

Lot Number	24392IL0
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Codes	Skin Discoloration (2074); Foreign Body Embolism (4439)
Date of Event	02/09/2026
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.The local deprivation of blood supply causes tissue anoxia.If enough hyaluronidase is injected on time, symptoms can be fully resolved without sequelae.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.This is default text configured for block h10.
Event or Problem Description
Sluggish capillary refill - vascular occlusion [vascular skin disorder] ([skin discolouration], [livedo reticularis]).Case narrative: on 12-feb-2026, primevigilance notified teoxane geneva of an adverse event.A patient was injected on (b)(6) 2026 with 0,1ml of rha 3 in the piriform fossa using the needle provided in the box.Immediately after the injection (on (b)(6) 2026), the injector noticed a darkening discoloration in the piriform fossa extending to the nose.The patient received 4 sessions of hyaluronidase (hylenex 75-250 iu).The initial discoloration was resolving but red and white lace-like pattern could be seen in the upper lip.Some sluggish capillary refill persisted but was < 3 seconds to return to baseline.Considering the seriousness of the event, the case was assessed as reportable.On 17-feb-2026, we received the confirmation that the symptoms were linked to a vascular occlusion and that they were resolved.Considering resolution of the symptoms, the case was considered closed.Imdrf code annex g is erroneous is this case (due to database issue).Please consider code g04127 ¿ syringe.

• Brand Name: RHA 3
• 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: 24412892
• Report Number: 3005975625-2026-00011
• Device Sequence Number: 10569303
• Product Code: LMH
• UDI-Device Identifier: 07640173234173
• UDI-Public: 01076401732341731024392IL017270928
• 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: Nurse
• Type of Report: Initial
• Report Date (Section B): 02/23/2026

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: Other
• Device Lot Number: 24392IL0
• 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: 02/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/28/2024
• 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: Required Intervention; Other
• Patient Sex: Female