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

Lot Number	UNKNOWN
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Angioedema (4536)
Date of Event	07/27/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The symptoms are monitored and additional information will be added to final report.
Event or Problem Description
Revance notified teoxane of an adverse event on 28-jul-2023.A patient was injected on(b)(6) 2023 with two teoxane products: 2 syringes of rha 4 (b)(4) in the midface and 1 ml of rha 3 in the lower face.The injections were done with the needle provided in the box.3 days after the injection, on (b)(6) 2023, the patient experienced angioedema in the eyes and lips, itching and a small facial rash.At the beginning, the patient was prescribed the following treatment antihistamine, but she didn't respond for treatment, so the practitioner prescribed corticosteroid methylprednisolone (medrol dose pack) and topical antihistamine diphenhydramine (benadryl cream) and cool compresses.The situation of the patient and symptoms evolution are monitored.No additional information is available at the time of this report.
Event or Problem Description
Revance notified teoxane of an adverse event on 28-jul-2023.A patient was injected on (b)(6) 2023 with two teoxane products: 2 syringes of rha 4 (b)(4) in the midface and 1 ml of rha 3 in the lower face.The injections were done with the needle provided in the box.Three (3) days after the injection, on (b)(6) 2023, the patient experienced angioedema in the eyes and lips, itching and a small facial rash.At the beginning, the patient was prescribed the following treatment antihistamine, but she didn't respond for treatment, so the practitioner prescribed corticosteroid methylprednisolone (medrol dose pack) and topical antihistamine diphenhydramine (benadryl cream) and cool compresses.Despite reminders, no updates were provided about the patient, thus the case was closed as is.
Additional Manufacturer Narrative
In the context of hyaluronic acid filler injections, some patients may develop a hypersensitivity reaction due to an ige-mediated immune response of the body to the injected product (type i hypersensitivity reaction).This may occur after initial or repeated exposure and result in the edema, erythema, pain, and itching characteristic of an allergic response.Regarding angioedema, some authors believe that most angioedema cases are due to physical urticaria or hereditary or acquired angioedema, respectively triggered by mild trauma, rather than ige-mediated histamine release.Nonetheless, in rare cases, ige-mediated antibody response to either the disinfection agent (e.G., chlorhexidine) or ha fragments or other filler components (e.G., lidocaine) is possible.Treatment depends on the severity, but if there is no spontaneous resolution, anti-inflammatory intake is recommended.The risk of such adverse reactions is mentioned in the instructions for use of teoxane filler products.

• 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: same as contact office ; SZ
• MDR Report Key: 17611147
• Report Number: 3005975625-2023-00589
• Device Sequence Number: 20466693
• Product Code: LMH
• UDI-Device Identifier: 07640173230045
• UDI-Public: 7640173230045
• Combination Product (Y/N): N
• 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: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/22/2023

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 Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/28/2023
• Supplement Date Received by Manufacturer: 07/28/2023
• Initial Report FDA Received Date: 08/24/2023
• Supplement Report FDA Received Date: 09/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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