MAUDE Adverse Event Report: TEOXANE SA RHA 2; HYALURONIC ACID DERMAL FILLER

Lot Number	24151AL0
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hypersensitivity/Allergic reaction (1907)
Date of Event	02/25/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
This case occured outside of usa in united kingdom.On 14-apr-2025 the uk subsidiary notified teoxane geneva about an adverse event.According to the information received, the patient was injected: - on (b)(6) 2024 with 1 ml of rha3 in the lips (0.3ml) and in the naso labial folds (0.7 ml) using retrotracing and fanning techniques, ar needle for the lips and a cannula for the nlf ((b)(4)).- on (b)(6) 2024 with 0.6 ml of rha 2 in the lips (0.4 ml) and in the oral commissures (0.2 ml) using retrotracing and fanning techniques, a needle for the lips and a cannula for the oral commissures.(current complaint).The patient also received injection of azzalure (botulinum toxin) in the glabella on (b)(6) 2024.Approximately 3 months after the last injections, around the (b)(6) 2025, the patient experienced an hypersensitivity reaction and was hospitalized for 2 days.This case was assessed as serious and reportable.The patient was prescribed the following treatments during her hospitalization: - antibiotic treatment (flucloxacillin).- prednisolone 30 mg reducing by 5 mg every 5 week until 6 weeks.- ppi omeprazole20 mg.A local medical expert was contacted for guidance.The later recommended hyaluronidase injection under ultrasound.An appointment with the injector was scheduled on (b)(6) 2025 to dissolve the three remaining lumps in the nlf area which were very tender.According to the information received on 28-apr-2025, the filler was dissolved in the area and the patient was happy with the results.Therefore, the case was closed.
Additional Manufacturer Narrative
Delayed allergic reactions that may manifest weeks to years after injection are well-known and documented reactions in the context of hyaluronic acid dermal filler injections.They are immune-mediated reactions that can be triggered by patient predisposition, trauma, vaccines, or infections.Adequate treatment usually leads to a good resolution of the symptoms, without sequelae.In addition, the risk of such reactions is mentioned in the instructions for use of products.

• Brand Name: RHA 2
• Common Device Name: HYALURONIC ACID DERMAL FILLER
• Manufacturer (Section D): TEOXANE SA; rue de lyon 105; geneva, 1203 ; SZ 1203
• Manufacturer Contact: celine vial
• MDR Report Key: 22016366
• Report Number: 3005975625-2025-00027
• Device Sequence Number: 21203179
• Product Code: LMH
• UDI-Device Identifier: 07640173230021
• UDI-Public: 01076401732300211024151AL017260430
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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): 04/14/2025

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: 04/30/2026
• Device Lot Number: 24151AL0
• 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: 04/14/2025
• Initial Report FDA Received Date: 05/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/30/2024
• 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: Hospitalization
• Patient Age: 41 YR
• Patient Sex: Female