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

Lot Number	TP27L-22471JL0
Medical Device Problem Codes	Off-Label Use (1494); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Foreign Body Embolism (4439)
Type of Reportable Event	Serious Injury
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, 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 3) is not indicated for this area.Therefore, this constitutes an off-label use for which the safety and performance of the product cannot be guaranteed.
Event or Problem Description
This case occured outside of the usa in spain.On 28-oct-2024, the spanish subsidiary notified teoxane geneva of an adverse event.According to the information received, a patient was injected on (b)(6) 2024 with 0.1 ml of rha 3 in the forehead using a bolus technique and the needle supplied in the box.The day of the injection, a vascular compromise was diagnosed.Therefore, the case was reportable.The same day, 6000 ui (dose to be confirmed) of hyaluronidase was injected, and the following treatments were prescribed: aspirine (adira 100) for 6 days, glucocorticoids treatment (dexametasona, 4mg) only once, sun cream.One day after the injection, on (b)(6) 2024, the patient received an antibiotic treatment (mupirocina), twice a day for 7 days and a new dose of hyaluronidase (unspecified amount).The patient has been injected in lips in 2020 with restylane kysse, and in 2021 and 2022 in lips with juvederm without any reaction.The patient has a history of acne and was under anti-acne treatment (isotretinoina 60 mg), the day of the injection.A medical expert contacted the injector.According to the information on (b)(6) 2024 received, the symptoms are partially resolved.

• 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: céline vial
• MDR Report Key: 20758556
• Report Number: 3005975625-2024-00644
• Device Sequence Number: 8671614
• Product Code: LMH
• UDI-Device Identifier: 07640173230045
• UDI-Public: 01076401732300451022471JL017241130
• 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

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 11/30/2024
• Device Lot Number: TP27L-22471JL0
• 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: 10/25/2024
• Initial Report FDA Received Date: 11/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/30/2022
• 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
• Patient Age: 23 YR
• Patient Sex: Unknown