MAUDE Adverse Event Report: TEOXANE SA RHA 2; HYALURONIC ACID DERMAL FILLER

Lot Number	23441AL0
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Foreign Body Embolism (4439)
Date of Event	10/28/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
According to the information received, this case seems to be linked to 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 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.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 14-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 0.4 ml of rha 2 in the temples using a 25-gauge cannula and the retracting technique.The day of the injection, on (b)(6) 2024, the patient experienced an increase in volume, looking as a hematoma in the left temple.The injector performed compression and massage.One day after the injection, on (b)(6) 2024, the patient reported a yellow-greenish color in the left temporal area, sensitivity in the area, and slight pain when touched.One day later, on (b)(6) 2024, the patient complained about the worsening of pain and the expension of the hematoma along the entire implantation line of the area.The injector proposed a new appointment, but the patient was not able to come.On (b)(6) 2024 the patient experienced alopecia plaque/hair loss upper the left temple.A local medical expert was contacted to make a diagnosis, and according to him, the alopecia was due to a compressive phenomenon, either from the hematoma caused by the injection of from the dermal filler itself.Therefore, this case is reported for a vascular compression.He also recommended antihypertensive and vasodilator treatment (3-5% minoxidil topically twice a day) on the alopecia plaque.According to the information received on (b)(6) 2024, the patient was stable, the alopecia plaque did not grow and the evolution of symptoms is being monitored.

• Brand Name: RHA 2
• 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: 20922804
• Report Number: 3005975625-2024-00678
• Device Sequence Number: 14725703
• Product Code: LMH
• UDI-Device Identifier: 07640173230021
• UDI-Public: 01076401732300211023441AL017251030
• 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): 12/13/2024

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: 10/30/2025
• Device Lot Number: 23441AL0
• 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: 11/14/2024
• Initial Report FDA Received Date: 12/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/30/2023
• 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: Unknown