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

Lot Number	TP27L-22421IL0
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hypersensitivity/Allergic reaction (1907)
Date of Event	10/11/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Localized allergic reactions that appear within minutes to hours are well-known and documented adverse reactions to hyaluronic acid filler injections.They are immune-mediated reactions related to patient conditions such as allergies to ha, lidocaine, or nickel composing the needle.With medical treatment, symptoms can be fully resolved quickly and without sequelae.In addition, the risk of such reactions is mentioned in the instructions for use of teosyal products.
Event or Problem Description
On (b)(6) 2023, the spanish subsidiary notified us of an adverse event.According to the information received, a patient was injected on (b)(6) 2023, with 0.1 ml of teosyal rha 3 in the upper lip.The injection was performed with a needle, using the retrotracing technique.The patient had previously injected another dermal filler in the lips (fillderma kiss) in 2021-2022, without presenting any adverse reactions.On the same day of the injection ((b)(6) 2023), the patient experienced a allergic reaction, hypersentivity type i reaction, in the upper lip, of moderate intensity.One of our local medical advisors immediately contacted the injector.The patient received injection of corticosteroid anti-inflammatory (urbason), and showed an important improvement.Additionally, oral corticosteroids (prednisone, 30 mg) were prescribed once a day for 5 days.Finally, on (b)(6) 2023, we were informed that the patient had fully recovered without any further complications.The complaint was considered closed.

• Brand Name: RHA 3
• 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, 1201 ; SZ 1201
• Manufacturer Contact: inés moreno pons ; rue de lyon 105; geneva, 1203 ; SZ 1203
• MDR Report Key: 18090079
• Report Number: 3005975625-2023-00765
• Device Sequence Number: 6669798
• Product Code: LMH
• UDI-Device Identifier: 07640173230045
• UDI-Public: 07640173230045
• 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): 11/08/2023

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: 10/31/2024
• Device Lot Number: TP27L-22421IL0
• 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: 10/13/2023
• Initial Report FDA Received Date: 11/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/31/2022
• 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: 24 YR
• Patient Sex: Female