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

Lot Number	22462KL0
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Embolism/Embolus (4438); Foreign Body Embolism (4439)
Date of Event	09/27/2023
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.The risk of such adverse reactions is mentioned in the instructions for use of teosyal products.
Event or Problem Description
This event occured outside the usa, in croatia.On (b)(6) 2023, an injector from croatia notified us of an adverse event.According to the information received, a patient was injected on (b)(6) 2023 with 1.2ml of teosyal rha 4 distributed bilaterally in the midface region (cheeks and deep pyriform fossa).Following the injection, on the same day, the patient presented with a vascular occlusion.The injector reported that after treating the left side of the face and finishing off with the left deep pyriform fossa, she noticed mottling of the skin and bluish discoloration in the area of distribution of the angular artery.The bluish discoloration progressed to the tip of the nose.The injector tested the capillary refill time and noticed it was reduced.Immediately, the injector decided to proceed with hyaluronidase injections (previous allergy tested), according to high pulse protocol.The patient received in total of 3 ampoules of hyaluronidase 1500 iu with 30 minutes of interval over a period of 6 hours.A clinical improvement was noticed immediately.The next day, the patient received another injection of hyaluronidase, because some mild mottling was still noticed in the nasolabial area and nasal ala.On (b)(6) 2023, the distributor informed us that a medical assistance was provided by a local medical expert.The patient was recovered and is now completely fine.On (b)(6) 2023, the local medical expert confirmed that the vascular occlusion was resolved.The complaint was considered closed.

• Brand Name: RHA 4
• Common Device Name: HYALURONIC ACID DERMAL FILLER
• Manufacturer (Section D): TEOXANE SA; rue de lyon 105; geneva, geneva 1203 ; SZ 1203
• Manufacturer Contact: same as contact office
• MDR Report Key: 17963729
• Report Number: 3005975625-2023-00708
• Device Sequence Number: 7669857
• Product Code: LMH
• UDI-Device Identifier: 07640173230069
• UDI-Public: 010764017323006922462KL017241130
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• 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): 10/19/2023

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: 11/30/2024
• Device Lot Number: 22462KL0
• 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: 09/28/2023
• Initial Report FDA Received Date: 10/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/30/2022
• 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 Age: 45 YR
• Patient Sex: Female