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

Lot Number	TP27L-22421JL0
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	10/04/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
This case occured outside the usa, in spain.On (b)(6) 2023, the spanish subsidiary notified us of an adverse event.According to the information received, a patient was injected on (b)(6) 2023 with 0.6ml of teosyal rha 3 in the chin (0.5ml) and in lower lip (0.1ml) (bolus technique).The same day, on (b)(6) 2023, the patient presented with a vascular occlusion in the chin of severe intensity.The injector was contacted by a local medical expert to provide medical assistance.The patient received on (b)(6) 2023 three cycles of hyaluronidase 1000iu injections and one more injection on (b)(6) 2023.The injector also prescribed nonsteroidal anti-inflammatory (aspirin 325mg) and steroid anti-inflammatory (fortecortin 8mg).According to the follow up information received on 18-oct-2023, the patient received hyaluronidase injections during 3 days in total and was then completely recovered.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 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.

• Brand Name: RHA 3
• 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: 18056240
• Report Number: 3005975625-2023-00730
• Device Sequence Number: 20348751
• Product Code: LMH
• UDI-Device Identifier: 07640173230045
• UDI-Public: 010764017323004510224
• 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): 10/20/2023

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: 10/31/2024
• Device Lot Number: TP27L-22421JL0
• 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: 10/05/2023
• Initial Report FDA Received Date: 11/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/31/2022
• 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: 49 YR
• Patient Sex: Female