MAUDE Adverse Event Report: TEOXANE SA RHA 4; HYALURONIC ACID DERMAL FILLER

Lot Number	TPUL-23392CL0
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Skin Inflammation/ Irritation (4545)
Date of Event	09/30/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
This case occured outside of the us in france.On 17-oct-2024, the french subsidiary notified us of an adverse event.According to the information received, a patient was injected on (b)(6) 2024, with rha 4 in nasolabial folds and in cheekbones (1,2 ml perside) with a needle.The same day the patient was injected in cheekbones with unknown amount of rha 4.No complaint was opened for this injection considering the reaction site.Approximately 3 months after the injection, on (b)(6) 2024, the patient experienced swelling, lumps inside the cheeks, induration and cardboard skin.One week later, on (b)(6) 2024, a secong phase of swelling started, with higher intensity.The patient was prescribed cortisone for 6 days, antibiotherapy and a ct scan exam.One week later, on (b)(6) 2024, the patient had drainage with ct scan assistance, liposuction, and rinsing.The patient was still swollen.9 days later, on (b)(6) 2024, the patient experienced swelling.According to the information received, the injector removed all nodules and asked for analysis.The analysis came back as normal.According to several medical doctors, no infection was diagnosed, only an inflammatory reaction.An auto-immune disease (not precified) has been suspected but not confirmed at this time.Since an inflammation has been diagnosed leading to an invasive medical intervention, this case is considered serious and reportable.According to the information received on 31-oct-2024, the patient's swelling decreased and is socially bearable.
Additional Manufacturer Narrative
Since an delayed inflammatory reaction and nodules have been diagnosed leading to an invasive medical intervention, this case is considered as serious and reportable.Delayed inflammatory reactions that may manifest as swelling, nodules, skin induration weeks to months after injection are well-known and documented reactions in the context of hyaluronic acid dermal filler injections.They may be related to a delayed immune response or to a bacterial infection.They can be triggered by patient predisposition, trauma, vaccines, or infections.With medical treatment, symptoms can be quickly fully resolved, without sequelae.In addition, the risk of such reactions is mentioned in the instructions for use of rha4 products.

• Brand Name: RHA 4
• Common Device Name: HYALURONIC ACID DERMAL FILLER
• Manufacturer (Section D): TEOXANE SA; rue de lyon 105; geneva, 1203 ; SZ 1203
• Manufacturer Contact: céline vial
• MDR Report Key: 20694031
• Report Number: 3005975625-2024-00623
• Device Sequence Number: 15313671
• Product Code: LMH
• UDI-Device Identifier: 07640173232704
• UDI-Public: 01076401732327041023392CL01730250930
• 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): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/15/2024

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: 09/30/2025
• Device Lot Number: TPUL-23392CL0
• 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: 10/16/2024
• Initial Report FDA Received Date: 11/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/30/2023
• 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