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

Lot Number	23341FL0
Medical Device Problem Codes	Improper or Incorrect Procedure or Method (2017); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Foreign Body Embolism (4439)
Date of Event	05/20/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
According to the information received, the case seems to be linked to a vascular compromise.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 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 products additionally, this teosyal product is not indicated for this area (nose).Therefore, this constitutes an off-label use for which the safety and performance of the product cannot be guaranteed.Batch analyses undertaken confirm that the products passed sterility and quality compliance tests, therefore the imputability of the product seems dismissed.
Event or Problem Description
This case occured outside of the usa in spain.On 21-may-2024, the spanish distributor notified us of an adverse event.However the email was lost and this case was opened only on 27-jan-2025 thanks to a reminder from the spanish subsidiary.A non conformity (ncr-000001312) has been therefore opened for this late opening of rc/2501064.According to the information received, a patient was injected on (b)(6) 2024 with rha 4 in the nose (radix and tip of the nose).The same day the patient experienced a wrong capillary refill in the nasal tip and received hyaluronidase injections (3000ui + 500ui in white lip and columnella).After the injection of hyaluronidase, the patient experienced a livedo in the glabella and in the white lip.The patient was prescribed an antibiotic treatment (mupirocin 2%) for 7 days and ains treatment (adiro 100) 7 days.The day after, on (b)(6) 2024, the patient received a new injection of hyaluronidase (500 ui) in the nasal dorsum.A local medical expert was contacted for guidance at this time and accompanied the injector with the injection of hyaluronidase.According to the information received on 27-jan-2025, the symptoms were resolved a few days after the occurence of this event.Therefore this case was closed.

• Brand Name: RHA 4
• Common Device Name: HYALURONIC ACID DERMAL FILLER
• Manufacturer (Section D): TEOXANE SA; rue de lyon 105; geneva 1203 ; SZ 1203
• Manufacturer Contact: céline vial
• MDR Report Key: 21460476
• Report Number: 3005975625-2025-00039
• Device Sequence Number: 7764110
• Product Code: LMH
• UDI-Device Identifier: 07640173232704
• UDI-Public: 01076401732327041023341FL017250831
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/25/2025

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: 08/31/2025
• Device Lot Number: 23341FL0
• 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: 05/21/2024
• Initial Report FDA Received Date: 02/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/31/2023
• 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 Age: 46 YR
• Patient Sex: Female