MAUDE Adverse Event Report: TEOXANE SA RHA 4; HYALURONIC ACID DERMAL FILLER

Lot Number	UNKNOWN (SEE SECTION B6)
Medical Device Problem Codes	Off-Label Use (1494); Use of Device Problem (1670)
Health Effect - Clinical Code	Embolism/Embolus (4438)
Date of Event	09/13/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Primevigilance notified teoxane of an adverse event on 18-sep-2024.A female patient was injected on (b)(6) 2024 with 1 syringe of rha 4 in the gonial angle, prejowl sulcus and nasolabial folds (0.2 on each side gonial angle and 0.2 prejowl sulcus and 0.2 nasolabial folds).The injection was done with unspecified needle.On the same day, the patient experienced a vascular occlusion in the jawline.The patient was treated with multiple rounds of hyaluronidase (hylenex): 5 vials of hyaluronidase (hylenex) first day and 2 vials on the next day, along with aspirin and warm compresses.Revance medical affairs team contacted the injector.The symptoms of vascular occlusion were considered as resolved in (b)(6) 2024.According to the resolution of the symptoms, the case was closed.
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 our products.Of note, rha 4 is not indicated for gonial angle and prejowl sulcus in the us.

• Brand Name: RHA 4
• Common Device Name: HYALURONIC ACID DERMAL FILLER
• Manufacturer (Section D): TEOXANE SA; rue de lyon 105; geneva, 1203 ; SZ 1203
• Manufacturer Contact: izabela bat
• MDR Report Key: 20470093
• Report Number: 3005975625-2024-00569
• Device Sequence Number: 18045563
• Product Code: LMH
• UDI-Device Identifier: 07640173232704
• UDI-Public: 7640173232704
• 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: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/17/2024

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: UNKNOWN (SEE SECTION B6)
• 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: 09/18/2024
• Initial Report FDA Received Date: 10/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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