MAUDE Adverse Event Report: TEOXANE SA RHA 2; HYALURONIC ACID DERMAL FILLER GEL

Lot Number	23222EL
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Foreign Body Embolism (4439)
Date of Event	07/08/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
This case occured outside of the usa, in australia.On 11-jul-2024, the australian subsidiary notified teoxane geneva of an adverse event.  a patient was injected on (b)(6) 2024 by a nurse with rha 2 in the nasolabial folds, in the oral commisures, and in the marionette lines.A 25g cannula was used to layer the acid hyaluronic in the subdermal and subcut planes.  the patient had a history of filler injections in the nasolabial folds and marionette lines, as well as botulinum toxin treatment on (b)(6) 2023 without any issue.  immediately after the injection, the patient presented with discolouration and laryngeal hypersensitivity syndrome (lhs) in the nasolabial folds (nostril).The same day, the prescribing doctor was contacted for a second opinion.He was unsure if there was a vascular occlusion and was advised to monitor the patient over the next 24 hours and review if needed.The patient did not present with any pain, and the symptoms seemed to subside after 10-15 minutes.Therefore, the symptoms were suspected of being hematoma.  the next day, on (b)(6) 2024, the patient contacted the treating nurse, sending a photo of the concerned area.The nurse suspected a livedo-reticularis pattern.Thus, an appointment was fixed the following day to treat the patient with hyaluronidase.  on (b)(6) 2024, the patient complained about pain inside her nostril.According to this new symptom, the nurse decided to treat the event as vascular occlusion with possible ulceration in the nostril and treated the patient as follows:  - the area was flooded with 3000u of hyalase (2x vials reconstituted with 3ml of lignocaine).- the area was massaged, and heat was applied.  following the treatment, the symptoms were fully resolved within 45 minutes.According to the resolution of the symptoms, the case was closed.  even though the diagnosis of vasular occlusion was not confirmed, the symptoms pointed to it.Therefore, the case was assessed as reportable to the australian competent authorities (tga).
Additional Manufacturer Narrative
According to the information received, this case seems linked to a vascular skin occlusion.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 rha 2.

• Brand Name: RHA 2
• 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: 19817395
• Report Number: 3005975625-2024-00460
• Device Sequence Number: 8589352
• Product Code: LMH
• UDI-Device Identifier: 07640173230021
• UDI-Public: 01076401732300211023222EL17240630
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 07/24/2024

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: 23222EL
• 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: 07/10/2024
• Initial Report FDA Received Date: 07/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/30/2023
• 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