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

Lot Number	23032BL0
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Foreign Body Embolism (4439)
Date of Event	09/20/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
According to the received investigation, this case seems to be a vascular compression.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 this rha 4 product.
Event or Problem Description
This case occurred outside of the usa, in italy.The italian subsidiary notified teoxane of an adverse event on 25-sep-2024.A patient was injected with 0.4 ml of rha 4 on the tip of the nose on (b)(6) 2024.7 months later, on (b)(6) 2024, the patient presented with redness on the tip of the nose of moderate intensity.As medical treatment on 24-sep-2024, the patient was prescribed the following : - kelairon cream, 1 time in the morning and 1 time in the evening, starting for 7 days; - gentalin beta cream, 1 time in the morning and 1 time in the evening, starting for 7 days.The local medical expert was contacted to provide support in this case.On 08-oct-2024, we were informed that the case was diagnosed as a vascular compression by the local medical expert on an unknown date.A treatment with 30 i.U.Of hyaluronidase was advised.Based on this diagnosis, the case was upgraded as reportable to the health competent authorities.On (b)(6) 2024, the patient was treated with 35 i.U.Of hyaluronidase in the nose and evolved favorably.On (b)(6) 2024, only a little redness was remaining.The injector planned to see the patient at the end of october to determine if an additional injection of hayluronidase was needed.On (b)(6) 2024, we were informed that the patient completely recovered.Thus, this complaint was considered closed.

• Brand Name: RHA 4
• 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: 20523761
• Report Number: 3005975625-2024-00579
• Device Sequence Number: 12758441
• Product Code: LMH
• UDI-Device Identifier: 07640173230069
• UDI-Public: 01076401732300691023032BL017240131
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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): 10/24/2024

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 Expiration Date: 01/31/2024
• Device Lot Number: 23032BL0
• 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: 10/21/2024
• Initial Report FDA Received Date: 10/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/31/2023
• 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 Sex: Female