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

Lot Number	23292FL0
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Movement Disorder (4412)
Date of Event	08/23/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
This case occured outside of the usa in australia.On 03-dec-2024, the australian subsidiary notified teoxane geneva of an adverse event.According to the information received on 12-jan-2025, a patient was injected with the following products: 1.2 ml of rha 4 in both mid cheeks on (b)(6) 2024 using a bd syringe and the bolus technique (current complaint).1.8 ml of ultra deep in both cheeks (0.8 ml) on (b)(6) 2024 and chin (1ml) using a bd syringe and the bolus technique (rc/2501030).1.0 ml of rha 3 in the lips on (b)(6) 2024 using a bd syringe and the bolus and fanning techniques.(rc/2501031).10 days later, on (b)(6) 2024, the patient experienced droppy right eye (possible eyelid ptosis).The patient was prescribed eye drops (pilocarpine), was advised to not touch the eye.Approximately 1 month later, on (b)(6) 2024, the eye symptoms improved and the eye drops were stopped.The international medical expert was contacted for guidance regarding the ptotis, and according to the information received on 30-jan-2025, this case might be eventually a case of ophthalmoplegia following ha fillers injections, without vision loss of other symptomatology as ha fillers can accidentally decrease blood flow to levator muscle.Therefore, from that date the case was assessed as reportable for this eye impairment.This case was reported to fda without respecting the timelines for reporting.A non-conformity (ncr-00000154) was opened in our qms.In addition, 3 months after the injection, on (b)(6) 2024, the patient experienced hard lumps (also reported as granulomas but never confirmed) of moderate intensity, hot skin and redness of moderate intensity in left marionette line, both cheeks and in the chin.The patient was prescribed steroids (prednisone 25 mg) for 7 days and antibiotics (klacid) for 7 days, both treatments starting on (b)(6) 2024.On (b)(6) 2024, the patient also experienced swelling of the face and areas of chin and cheeks.On (b)(6) 2024, an intralesional steroid was injected to the patients (1ml of 10% kena kort with 0.5 ml of lydocaïne with 2% of adrenaline).The steroids treatment was reduced to 10 mg for 7 days and a new antibiotic treatment (minocycline 10 mg daily) was initiated.A potential infection was mentioned by the nurse in her notes but was also never confirmed.On (b)(6) 2024, the hard lumps were improving but a new area of the lateral lips was swollen.Despite several reminders no additional information was retrieved, therefore the case was closed as this.
Additional Manufacturer Narrative
According to the information received, this case seemed to be linked to an injection site movement impairment, diagnosed as a potential ophthalmoplegia.Local reactions that may manifest as movement impairment after injection are well-known and documented adverse reactions to hyaluronic acid filler injections.These reactions are related to the traumatic environment of the injection, vary according to injection volume, technique, and patient factors, and are usually resolved spontaneously.Several causes have been hypothesized in the literature, including nerve compression (by the product or by tissue swelling following the procedure).In turn, this can induce pain and other complications, such as a transient loss of sensitivity in the affected areas.In addition, the risk of such adverse reactions is mentioned in the instructions for use of products.It has to be noted that in this case other symptoms were reported after the resolution of this reaction, assessed as delayed inflammatory reactions.Delayed inflammatory reactions that may manifest as lumps, induration, hot skin, redness, swelling, weeks to years 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.Additionally, rha 4 product, was injected to the patient with a bd syringe.Rha 4 product is a ready to use product.Product deconditioning constitutes a misuse use for which the safety and performance of the product cannot be guaranteed.

• 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: 22184580
• Report Number: 3005975625-2025-00046
• Device Sequence Number: 20986862
• Product Code: LMH
• UDI-Device Identifier: 07640173232704
• UDI-Public: 01076401732327041023292FL017250730
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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: Other Health Care Professional
• 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: 07/30/2025
• Device Lot Number: 23292FL0
• 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: 12/03/2024
• Initial Report FDA Received Date: 06/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/30/2023
• 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