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

Lot Number	TP27L-2407R3L0
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hypersensitivity/Allergic reaction (1907)
Date of Event	11/06/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
According to the information received, this case seems to be linked to a type i hypersensitivity.Localized allergic reactions that may manifest as inflammation 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 rha 3 products.
Event or Problem Description
This case occured outside the usa, in france.On (b)(6)2024, the spanish subsidiary notified teoxane (b)(6) of an adverse event.A patient was injected on (b)(6)2024 with a total of 0,7ml of rha 3 in the lips (0,5ml in the upper lip and 0,2ml in the lower lip) using retrograde injection technique and the needle provided in the box (tsk 27g/13mm).The day before the injection (on (b)(6)2024), the patient had a dental extraction.According to the information received, the patient experienced a moderate inflammation on the upper lip after the injection (on (b)(6)2024) reported as "similar to an allergic reaction" and visited the emergency room.She received an intravenous antihistamine (polaramine) and left with a prescription of oral antihistamine (polaramine 2mg, 3 times per day for 3 days).Considering the severity of the symptoms assessed on the pictures received, this case was considered reportable.On (b)(6)2024, the local medical expert was put in contact with the injector who explained that symptoms improved with antihistamine treatment.On (b)(6)2024, we received the information that the symptoms improved favorably.

• 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: anais moreau
• MDR Report Key: 20819032
• Report Number: 3005975625-2024-00665
• Device Sequence Number: 7851165
• Product Code: LMH
• UDI-Device Identifier: 07640173230045
• UDI-Public: 0107640173230045102407R3L017260228
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/03/2024

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: 02/28/2026
• Device Lot Number: TP27L-2407R3L0
• 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: 11/07/2024
• Initial Report FDA Received Date: 12/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/29/2024
• 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: 28 YR
• Patient Sex: Female