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

Lot Number	UNKNOWN (SEE SECTION B6)
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Foreign Body Embolism (4439)
Date of Event	11/18/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Prime vigilance notified teoxane of an adverse event on november 20-nov-2023.A patient was injected on (b)(6) 2023 with 2 ml of teosyal rha 3 in the marionette lines.The injection was done with the 22g cannula, using the superficial technique.On the same day after the injection on (b)(6) 2023, the patient experienced pain and bruising, which was diagnosed by the injector as a vascular occlusion on the lower right marionette line.As a corrective action, the injector used hyaluronidase (hylenex) to dissolve the filler.At the time of this report, the outcome of the event was not recovered.Situation of the patient and symptoms evolution are monitored.No additional information is available at the time of this report.
Additional Manufacturer Narrative
The symptoms are monitored and additional information will be added to final report.
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 rha 3 products.
Event or Problem Description
Primevigilance notified teoxane of an adverse event on november (b)(6) 2023.A patient was injected on (b)(6) 2023 with 2 ml of teosyal rha 3 in the marionette lines.The injection was done with the 22g cannula, using the superficial technique.On the same day after the injection on (b)(6) 2023, the patient experienced pain and bruising, which was diagnosed by the injector as a vascular occlusion on the lower right marionette line.As a corrective action, the injector used hyaluronidase (hylenex) to dissolve the filler.At the time of this report, the outcome of the event was not recovered.Despite reminders, no updates was provided about the patient, thus the case was closed as is.

• Brand Name: RHA 3
• 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: 18345746
• Report Number: 3005975625-2023-00857
• Device Sequence Number: 6221949
• Product Code: LMH
• UDI-Device Identifier: 07640173230045
• UDI-Public: 7640173230045
• 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: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 01/16/2024

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: UNKNOWN (SEE SECTION B6)
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/20/2023
• Supplement Date Received by Manufacturer: 11/20/2023
• Initial Report FDA Received Date: 12/18/2023
• Supplement Report FDA Received Date: 01/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: 40 YR
• Patient Sex: Female