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

Lot Number	23161IL0
Medical Device Problem Code	Biofilm coating in Device (1062)
Health Effect - Clinical Code	Skin Infection (4544)
Date of Event	07/31/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Biofilms that appear weeks to years after injection are well-known and documented adverse reactions to hyaluronic acid filler injections.They occur when injected filler material becomes contaminated with bacteria.This process gives rise to a permanent low-grade chronic infection, and it may eventually lead to a chronic granulomatous reaction.Given the sterility of the gel, they are rather due to a lack of asepsis during injection and/or posttreatment care.It can also occur by reactivating a previously quiescent biofilm that formed after a previous filler treatment or after a bacteremia.Appropriate treatment allows progressive resolution of the symptoms.The risk of such reactions is mentioned in the instructions for use of this rha 4.
Event or Problem Description
This case occurred outside of the usa, in spain.The spanish subsidiary notified teoxane geneva of an adverse event on 15-aug-2024.A patient was injected on (b)(6) 2024 with the following products: 1 ml of teosyal puresense ultra deep in the middle third and cheekbones, (rc/2408032).1.2 ml of rha 4 in the nasolabial folds, labiomentalis groove, and in the cheeks (current complaint).Other products (rha3, and teosyal puresense redensity 2) were injected on the same day but no adverse events were reported at these injection sites.The patient also had a history of teoxane injections with the same products in 2023 in the middle third, nalolabialfolds, and maroinette lines without any issue.Approximatively 3 months after the injection, on (b)(6) 2024 (the date needs to be confirmed because of contradictory information), the patient noticed mild facial inflammation accompanied by induration on cheekbones, especially on the right side.The patient noticed it while being on the beach and while doing sports, and the symptom was confirmed on (b)(6) 2024 during a consultation.The patient was prescribed a tapering dose of corticosteroid (prednisone 30 mg) for 12 days, an antibiotic (ciproflaxine 500 mg) for 7 days, and one vial of hyaluronidase.9 days later, on (b)(6) 2024, the patient complained about a moderate inflammation in the nasolabial folds on both sides.She was prescribed a food supplement (drainaqua) and a wound treatment (varidase).The medical history of the patient mentioned a history of herpes and a dental surgery reported as being on (b)(6) 2024.On (b)(6) 2024, a blood test (blood count) was performed without leukocytosis.In addition, the patient had no fever or symptoms, as well as no redness or heat in the area.On (b)(6) 2024, we were informed that the local medical expert was contacted, and according to him, the symptoms described could be linked to a biofilm.Therefore, he advised to extend the antibiotic regimen to 2 weeks and to inject hyaluronidase.According to this new diagnosis, the case was upgraded too reportable.On (b)(6) 2024 (date of the initial email) the symptoms were resolving; the symptoms were resolving.At the time of this report, no additional information is available, but the situation and symptoms remain monitored.

• Brand Name: RHA 4
• Common Device Name: HYALURONIC ACID DERMAL FILLER GEL
• Manufacturer (Section D): TEOXANE SA; rue de lyon 105; geneva, 1203 ; SZ 1203
• Manufacturer Contact: omar mounir ; rue de lyon 105; geneva, 1203 ; SZ 1203
• MDR Report Key: 20246526
• Report Number: 3005975625-2024-00511
• Device Sequence Number: 15262639
• Product Code: LMH
• UDI-Device Identifier: 07640173232704
• UDI-Public: 01076401732327041023161IL017250430
• 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: 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): 09/18/2024

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: 04/30/2025
• Device Lot Number: 23161IL0
• 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: 08/15/2024
• Initial Report FDA Received Date: 09/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/30/2023
• 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