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

Lot Number	TPUL-22402HL0
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Foreign Body Embolism (4439)
Date of Event	05/28/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
On june 20, 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 0.6 ml of teosyal rha 4 in the nasolabial folds.The injection was done with a needle using the retrotracing technique.On the same day, the practitioner noticed a vascular compromise, as the patient presented with livedo reticularis on the nose, the left nasolabial fold and the white lip.As a corrective action, 600 ui of hyaluronidase were immediately administered (four injections of 150 ui) and the following treatment was prescribed: - nonsteroidal anti-inflammatory drug (aspirin 300 mg): 1 tablet.- topical antibiotic: (mupirocin 2%): twice a day for 7 days.One day after the injection, on (b)(6) 2023, another 1500 ui of hyaluronidase were administered (one injection), and the following treatment was prescribed: - nonsteroidal anti-inflammatory drug (aspirin 100 mg): 1 tablet per day for 7 days.Finally, on june 20, 2023, we were informed that the vascular compromise was fully resolved without any further complications.
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: 17246460
• Report Number: 3005975625-2023-00504
• Device Sequence Number: 20051614
• Product Code: LMH
• UDI-Device Identifier: 07640173230069
• UDI-Public: 01076401732300691022402HL017241031
• 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): 07/03/2023

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-22402HL0
• 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: 06/20/2023
• Initial Report FDA Received Date: 07/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/31/2023
• 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 Age: 36 YR
• Patient Sex: Male