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

Lot Number	TPUL-22412BL0
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Foreign Body Embolism (4439)
Date of Event	06/22/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2023, the spanish subsidiary notified us of an adverse event following the use of teosyal rha 4 in a patient.According to the information received, a patient was injected on (b)(6) 2023, with 1.2 ml of teosyal rha 4 in the nasolabial folds.The injection was done using the retrotracing technique.On the same day, the patient experienced a vascular compromise, as he presented with livedo reticularis, pain, and inflammation on the left nasolabial fold, as well as fever.As a corrective action, 200 iu of hyaluronidase were administered on (b)(6) 2023, and antibiotics (azithromycin 500 mg, 1 tablet per day) were prescribed.On (b)(6) 2023, we were informed that the patient had gone to the emergency room on (b)(6) 2023, as he still suffered from fever and intense pain.The injector stated that there were no signs of necrosis in the picture.On (b)(6) 2023, our medical advisor insisted on the need to inject more hyaluronidase.On (b)(6) 2023, we were informed that, although the patient did not come back for his consultation, the injector found out that he was completely fine.As it appeared in the photos, this adverse event was likely a mild vascular compromise, induced by inflammation and compression, and it was fully resolved.Therefore, this case was considered closed.
Additional Manufacturer Narrative
Vascular complications are rare and serious side effects, although they are widely known and documented in the context of filler injections.They are related to the accidental injection of the product inside or close to a blood vessel, leading to its occlusion or compression, blocking the blood flow.If treated on time with an appropriate treatment, symptoms can be fully resolved without sequalae.If the vascular complication is not detected/diagnosed and treated propmtly, it can lead to skin necrosis.The risk of such adverse reactions is mentioned in the instructions for use of teosyal products.

• 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 (Section G): TEOXANE SA; rue de lyon 105; geneva, 1203 ; SZ 1203
• Manufacturer Contact: ines moreno pons ; rue de lyon 105; geneva, 1203 ; SZ 1203
• MDR Report Key: 17332124
• Report Number: 3005975625-2023-00518
• Device Sequence Number: 6647219
• Product Code: LMH
• UDI-Device Identifier: 07640173230069
• UDI-Public: 01076401732300691022412BL017241031
• 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: 2023
• 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): 07/17/2023

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: 10/31/2024
• Device Lot Number: TPUL-22412BL0
• 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: 06/27/2023
• Initial Report FDA Received Date: 07/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/31/2022
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 36 YR
• Patient Sex: Male