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

Lot Number	22502EL0
Medical Device Problem Codes	Off-Label Use (1494); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Foreign Body Embolism (4439)
Date of Event	03/01/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Primevigilance notified teoxane of an adverse event on 04-mar-2024.A patient was injected on (b)(6) 2024 with 0.5 ml of rha 4 in the temple.The injection was done superficially and above the fascial tissue plane with the 25g cannula.  two minutes after the injection, on (b)(6) 2024, the patient presented blanching posterior to the injection point, which spread to the right cheek.Capillary refill was checked, and the injector diagnosed vascular occlusion.  due to the diagnosis, within five minutes, 16 vials hyaluronidase (hylanex) was injected and capillari refill returned.In addition, the injector put warm compresses, massaged the area and prescribed a non steroidial anti-inflammatory drug (acetylsalicylic acid , 325 mg), the following day, on (b)(6) 2024, the symptoms seemed to get worse, so the patient was treated by another health care professional who used a ultrasound to guide hyaluronidase treatment.During the procedure, patent blood flow was observed.It was then planned to treat the patient with hyperbaric oxygen to the affected area (eo2 treatment).At the time we received the initial information, the symptoms were resolving.The history of the patient also mentioned injection with rha 3 on (b)(6) 2024 but either the injection site, the batch number, nor any other details about the injection were provided.According to the information received, this product was not considered to be involved in the adverse reaction reported.Therefore, no additional complaint was opened for rha 3.  the case was closed.
Additional Manufacturer Narrative
According to the information received, this case is related to the vascular complication.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.The risk of such adverse reactions is mentioned in the instructions for use of products.Of note, rha 4 is not indicated for this area 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: paulina pietrucha
• MDR Report Key: 19017652
• Report Number: 3005975625-2024-00155
• Device Sequence Number: 19803562
• Product Code: LMH
• UDI-Device Identifier: 07640173233800
• UDI-Public: 07640173233800
• 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: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/02/2024

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 Expiration Date: 12/16/2024
• Device Lot Number: 22502EL0
• 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: 03/04/2024
• Initial Report FDA Received Date: 04/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/16/2022
• 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