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

Lot Number	TPUL-221029B0
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Foreign Body Embolism (4439)
Date of Event	07/06/2023
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.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 teosyal products.
Event or Problem Description
On july 7, 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, the injector performed a non-surgical rhinoplasty and injected 0.4 ml of teosyal rha 4 in the "patient's" nose and nasal columella to support the tip of the nose on (b)(6) 2023.One day after the injection, on (b)(6) 2023, the practitioner noticed a vascular compromise with symptoms of ecchymosis, whitening, and pain on the upper gums, caused by a puncture of the columellar artery.As a corrective action, 1000 ui of hyaluronidase were immediately administered, and the following treatment was prescribed: intramuscular corticosteroids: urbason 60 mg.Oral corticosteroids: prednisone 10 mg (once every 8 hours).Nonsteroidal anti-inflammatory drugs: aspirin 300 mg (1 tablet) and aspirin 100 mg (1 tablet every 12 hours).Warm compresses.Vasodilator: sildenafil 50 mg (once a day).Finally, on the same day, we were informed that the vascular compromise was fully resolved without any further complications.

• 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: 17350171
• Report Number: 3005975625-2023-00542
• Device Sequence Number: 17416076
• Product Code: LMH
• UDI-Device Identifier: 07640173230069
• UDI-Public: 0107640173230069102
• 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): 07/19/2023

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: 03/31/2024
• Device Lot Number: TPUL-221029B0
• 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: 07/07/2023
• Initial Report FDA Received Date: 07/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/31/2022
• 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: 51 YR
• Patient Sex: Female