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

Lot Number	TPUL-24022HL0
Medical Device Problem Codes	Off-Label Use (1494); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Foreign Body Embolism (4439)
Date of Event	09/02/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
This case occured outside of the us in spain.On 25-oct-2024, a doctor from spain notified teoxane geneva of an adverse event.According to the information received, a patient was injected on (b)(6) 2024 with 0.8 ml in lips (0.6 ml in upper lip and 0.2 ml in lower lip) with rha4.Other unspecified ha products were injected on (b)(6) 2019 and on (b)(6) 2022 in lips, and 1 ml of kiss was also injected in lips on (b)(6) 2023, with no incidence for the patient.Immediately after the last injection of rha 4, on (b)(6) 2024, a hematoma of moderate intensity appeared, and the same day a compression of the lower labial artery was diagnosed.Considering the diagnosis of vascular skin disorder, this case is serious and reportable.2 days after the injection, on (b)(6) 2024, the patient received an injection of (b)(4) units of hyaluronidase and was prescribed the following treatments: glucocorticoids treatment (deflazacort) for 7 days; antibiotic treatement (mupirocin) for 7 days; asa (aspirina/augmentina) for 10 days.According to the information received on 26-oct-2024, the adverse event is fully resolved.Then the case was closed.
Additional Manufacturer Narrative
According to the information received, the case seems to be linked to a vascular skin disorder.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 products.Additionally, this product (rha 4) is not indicated for this area (lips).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.

• Brand Name: RHA 4
• Common Device Name: HYALURONIC ACID DERMAL FILLER
• Manufacturer (Section D): TEOXANE SA; rue de lyon 105; geneva, ; SZ
• Manufacturer Contact: céline vial
• MDR Report Key: 20756948
• Report Number: 3005975625-2024-00641
• Device Sequence Number: 13077336
• Product Code: LMH
• UDI-Device Identifier: 07640173232704
• UDI-Public: 01076401732327041024022HL017260130
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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): 11/22/2024

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: 01/30/2026
• Device Lot Number: TPUL-24022HL0
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/25/2024
• Initial Report FDA Received Date: 11/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/30/2024
• 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: Unknown