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

Lot Number	TP27L-22381BL0
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Foreign Body Embolism (4439)
Date of Event	09/27/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
This case occured outside of the usa, in australia.A nurse notified teoxane of an adverse event on (b)(6) 2023.A patient was injected with: - 2 ml of teosyal rha 3 in the chin (mentalis crease) and in the marionette lines on (b)(6) 2023.The injection was done with a cannula, using the fanning technique.One day after the injection, on (b)(6) 2023, the patient presented with a vascular occlusion (sluggish cap refill), big lump, pain, and extending bruising (considered as a skin discolouration) of severe intensity, in the right lower lip and in the right marionette area.On (b)(6) 2023, the patient presented with inflammation of low intensity in the right lower lip.According to the information received on 05-oct-2023, the injector provided the following medical treatment to the patient: a vial of hyalase 1500 i.U to the chin, lip and marionette lines for 60 minutes on (b)(6) 2023, a vial of hylase 30 i.U, on (b)(6) 2023.A vial of hyalase 600 i.U, on (b)(6) 2023.Zyrtec (an antihistaminic), unknown quantity, on (b)(6) 2023.On 09-oct-2023, we were informed that all the symptoms resolved.The complaint was considered 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.The local deprivation of blood supply causes tissue anoxia.If enough hyaluronidase is injected on time, symptoms can be fully resolved without sequelae.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.

• 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
• MDR Report Key: 17905566
• Report Number: 3005975625-2023-00732
• Device Sequence Number: 7822506
• Product Code: LMH
• UDI-Device Identifier: 07640173230069
• UDI-Public: 0107640173230069102239LGLI17230930
• 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: 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): 10/10/2023

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: 09/30/2024
• Device Lot Number: TP27L-22381BL0
• 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: 10/01/2023
• Initial Report FDA Received Date: 10/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/30/2023
• 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