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

Lot Number	23012AL0
Medical Device Problem Codes	Off-Label Use (1494); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Foreign Body Embolism (4439)
Date of Event	04/17/2024
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.Of note, rha redenisty is not indicated for chin, marionette lines and tear troughs in the us.
Event or Problem Description
Primevigilance notified teoxane of an adverse event on (b)(6) 2024.The patient was injected on (b)(6) 2024 with a total of 2 ml of rha redensity in the marionette lines (0.25 ml on each side), chin (0.5 ml), and tear trough (1 ml).The injections were done with a 25g cannula.  during the injection, the skin around the right marionette blanched.The area was massaged, and the capillary refill was checked and was slow (taking 2-3 seconds).The patient did not report pain in the area but was under constant medical observation until the capillary refill returned to normal.After the patient left the clinic, the injector continued to closely follow-up with the patient with photos and videos.In the evening, the patient presented with mottling and delayed capillary refill and immediately went back to the clinic to be treated with 900 i.U.Of hyaluronidase (hylenex).The event was diagnosed as a vascular occlusion of moderate intensity.On (b)(6) 2024, the capillary refill returned to normal limits, but the affected area was still looking mottled.Thus, until (b)(6) 2024, the injector continued to treat the patient with hyaluronidase (a total of 4700 units in three days).  in addition, the injector prescribed the following treatment: - from (b)(6) 2024 to (b)(6) 2024 non-steroid anti-inflamatory drug (aspirin, 81 mg) - from (b)(6) 2024 to (b)(6) 2024 vasodylatator (viagra, 50 mg) to open up blood flow  - warm compresses on (b)(6) 2024, the symptoms completely resolved.Thus, the case was closed.

• Brand Name: RHA REDENSITY
• Common Device Name: HYALURONIC ACID DERMAL FILLER
• Manufacturer (Section D): TEOXANE SA; rue de lyon 105; geneva, 1203 ; SZ 1203
• MDR Report Key: 19330071
• Report Number: 3005975625-2024-00285
• Device Sequence Number: 19602073
• Product Code: LMH
• UDI-Device Identifier: 07640173231653
• UDI-Public: 7640173231653
• 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: Nurse
• Type of Report: Initial
• Report Date (Section B): 05/16/2024

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: 01/02/2026
• Device Lot Number: 23012AL0
• 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: 04/19/2024
• Initial Report FDA Received Date: 05/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/02/2023
• 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: Female