MAUDE Adverse Event Report: TEOXANE SA RHA 3; HYALURONIC ACID DERMAL FILLER

Lot Number	22461AL0
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Foreign Body Embolism (4439)
Date of Event	04/27/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
According to the information received, this case would be related to the vascular occlusion.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 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.
Event or Problem Description
Primevigilance notified teoxane of an adverse event on 02-may-2024.The patient was injected on (b)(6) 2024 with 0.3 ml of rha 3 in the lips, using a 30g needle.  during the injection, the injector noticed immediate blanching at the injection site, followed by a hematoma towards the middle of the lip.The patient was treated with a warm compress and acetylsalicylic acid (aspirin).As the capillary refill was slow,  the patient was treated with 2.5 vials of hyaluronidase (hylenex).The day after, on (b)(6) 2024, the patient was treated with 9 additional vials of hyaluronidase, applied bilaterally along with continued heat, massage, and aspirin.The same day, the capillary refill returned to normal.On (b)(6) 2024, the symptoms had resolved with only some reticular markings on the lip and a sore inside the lip in the mucosa remaining.The same day, the patient began hyperbaric oxygen therapy.Based on the information received, all the symptoms seem to point to a vascular occlusion.Thus, the case was assessed as reportable to the fda.  according to the resolution of the symptoms, the case was closed.

• Brand Name: RHA 3
• Common Device Name: HYALURONIC ACID DERMAL FILLER
• Manufacturer (Section D): TEOXANE SA; rue de lyon 105; geneva, 1203 ; SZ 1203
• Manufacturer Contact: paulina pietrucha ; SZ
• MDR Report Key: 19403791
• Report Number: 3005975625-2024-00310
• Device Sequence Number: 17839231
• Product Code: LMH
• UDI-Device Identifier: 07640173230045
• UDI-Public: 7640173230045
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/28/2024

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: 11/14/2025
• Device Lot Number: 22461AL0
• 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: 05/02/2024
• Initial Report FDA Received Date: 05/28/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/14/2022
• 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 Sex: Female