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

Lot Number	TPUL-24022HL0
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Foreign Body Embolism (4439)
Date of Event	11/14/2024
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 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.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 15-nov-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 0.3 ml of rha 4 in the mandibular angles on both sides and with 0.5 ml of ultra deep in the cheekbones.During the injection in the mandibular angle, the injector noticed that the right side of the lateral nose got a bit white, but she checked the capillarity refilled which was normal.The injection of hyaluronic acid was stopped, but hyaluronidase was not injected.The same day, late at night, the patient sent some pictures, and the injector diagnosed a livedo reticularis/isquemia reaction of severe intensity of the facial artery.A local medical expert has been contacted and confirmed it was a vascular compromise of the facial artery.During the following days, the injector has injected a total of 7.000 ui of hyaluronidase from the mandibular line to the nose, and the capillary refill returned to normal.The injector prescribed the following treatments: - anabolic androgenic steroids, - corticosteroids (prednisone), - antibiotics (orbenin, ciprofloxacin), - organic nitrates (rectogesic) and - 2 sessions of hyperbaric chamber.According to the information received on 29-nov-2024, the symptoms fully resolved.Then the 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: 20890525
• Report Number: 3005975625-2024-00682
• Device Sequence Number: 12723400
• Product Code: LMH
• UDI-Device Identifier: 07640173232704
• UDI-Public: 01076401732327041024022HL017260130
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: P17002
• 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): 12/10/2024

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
• 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: 11/15/2024
• Initial Report FDA Received Date: 12/10/2024
• 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 Sex: Male