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

Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Codes	Necrosis (1971); Foreign Body Embolism (4439)
Date of Event	10/11/2023
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 sequalae.If the vascular complication is not detected, diagnosed, and treated promptly, it can lead to skin necrosis.On day 2, the tissues often develop a deep bluish discoloration that looks like a "deep bruise", but capillary compression testing shows abnormal delay in capillary refill, and 1-2 days later the blister phase indicates the first signs of skin necrosis.The risk of such adverse reactions is mentioned in the instructions for use of teosyal products.
Event or Problem Description
This case occurred outside of the usa, in france.A physician notified teoxane of an adverse event on (b)(6) 2023.A patient was injected with 0.3 ml of teosyal rha 3 in the nose.Two days after the injection, the patient presented with a moderate necrosis at injection site.According to the information received on (b)(6) 2023, the injector provided the following medical treatment to the patient: 3 vials of hyalase, on (b)(6) 2023, antibiotics (unknown quantity and duration), aspirin (an anti-inflammatory, unknown quantity), corticosteroides, (unknown quantity and duration), led and hyperbaric oxygen therapy.Following the treatment, all the symptoms were partially resolved.And despite reminders, we were not able to obtain additional information about the complete resolution of the symptoms.Thus, the complaint was closed.

• 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 Contact: omar mounir ; rue de lyon 105; geneva, 1203 ; SZ 1203
• MDR Report Key: 18140653
• Report Number: 3005975625-2023-00761
• Device Sequence Number: 15100029
• Product Code: LMH
• UDI-Device Identifier: 07640173230045
• UDI-Public: 01076401732300451022491GL017241231
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: P170002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/15/2023

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: 12/31/2024
• 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: 10/19/2023
• Initial Report FDA Received Date: 11/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/31/2023
• 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