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

Lot Number	22482CL0
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	03/21/2024
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 this area 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 1 ml of rha redensity in the lips.The injection was done with a cannula using the retrotracing technique.Before the procedure, the patient received lidocaine and an epinephrine injection near to the oral commissures.  the medical history of the patient mentioned hypothyroidism and several medications: levothyroxine (synthroid) and plexus in addition to multivitamins, vitamin c, and vitamin d five minutes after the injection, on (b)(6) 2024, the injector noticed that lips started turning pale and capillary refill slowed.The patient felt ''numb''.A vascular occlusion was diagnosed.The patient was under observation for 1.5 hours.During this time, as a treatment, the injector used 1 ml of hyaluronidase (hylenex) on the left side of the perioral area via cannula and gave a warm compress.After that, the affected area and capillary refill improved.The injector massaged the affected area, and then the area became white again, but the capillary refill was good.An additional 0.5 ml of hyaluronidase (hylenex) was used, and the lips returned to their pink color.Around 1.5 hours after the treatment, the injector noticed bruising on the right upper lip.However, the capillary refill was less than 2 seconds, the mucosa looked good, and the patient was not experiencing any pain.  the following day, on (b)(6) 2024, the patient visited another provider who said that the patient's lips were good, but noticed that the capillary refill was sluggish.The doctor was not sure if it was due to the bruising so a third session of hyaluronidase (0.4 ml of hylenex) was injected, and the capillary refill went back to normal.Mucosa looked good, and the patient was not experiencing any pain.  on (b)(6) 2024, the practitioner noticed that the upper right quadrant of the lip, where the vascular occlusion occurred looked flattened but the capillary refill was excellent, and the bruise was resolving.Based on the resolution of the symptoms, 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: 19189303
• Report Number: 3005975625-2024-00212
• Device Sequence Number: 18065881
• 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): 04/26/2024

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: 11/29/2025
• Device Lot Number: 22482CL0
• 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: 03/27/2024
• Initial Report FDA Received Date: 04/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/29/2022
• 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