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

Lot Number	23152EL0
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Skin Infection (4544)
Date of Event	07/22/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
This case occured outside of the usa, in spain.On (b)(6) 2024, the spanish subsidiary notified teoxane geneva of an adverse event.A patient was injected with: - on (b)(6) 2024: 1.2ml of teosyal puresense ultra deep into the malar area (bolus with the needle 27g, rc/2408007), - on (b)(6) 2024 : 2ml of rha 4 into the cheekbones and marionette lines (bolus + retrograde injection, current complaint), - on (b)(6) 2024: 3ml of teosyal puresense redensity 1 into the dermis of a unknown area (retrograde injection, rc/2408008), - on (b)(6) 2024: 1.2ml of rha 4 into the cheekbones and nasolabial folds (current complaint), - on a unknown date: 1ml of teosyal puresense redensity 2 into tear trough, upper lips and perioral lines (rc/2408006).Approximately 1 month after the latest injection, on (b)(6) 2024, the patient experienced two inflammatory nodules (one into the left tear trough and the second into the left marionette line), soft and painful to palpation, plus an erythema into the left tear trough.On (b)(6) 2024, le patient consulted her injector and started a treatment by prednisone 1mg/kg/day.On (b)(6) 2024, the patient saw again her injector and received intralesional hyaluronidase injection and continued prednisone 1mg/kg for 4 days on (b)(6) 2024, the injector suggested continuing prednisone treatment due to increased swelling.On (b)(6) 2024, a decrease in the lesion was observed in the marionette lines and only very slight improvement in the malar area.Prednisone was maintained at 1 mg/kg, due to a sensation of global swelling of the face but progressive reduction was recommended in 48 hours, until the new visit on (b)(6) 2024.On (b)(6) 2024, we were informed that a local medical expert was contacted and proposed to add antibiotic to treat a possible case of biofilm since the inflamed areas corresponded to insertion points of the cannula.An appointment and a third dose of hyaluronidase was performed on (b)(6) 2024.At the time of this report and despite several reminders, no further information could be retrieved.
Additional Manufacturer Narrative
According to the information received, this case seems linked to a skin infection.Biofilms that appear weeks to years after injection are well-known and documented adverse reactions to hyaluronic acid filler injections.Common skin colonizing bacteria adhere to the gel and surround themselves with secreted polymers.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 the injection during injection and/or posttreatment care.Appropriate treatment allows progressive resolution of the symptoms.The risk of such reactions is mentioned in the instructions for use of rha 4 product.

• 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: 20008677
• Report Number: 3005975625-2024-00496
• Device Sequence Number: 20647528
• Product Code: LMH
• UDI-Device Identifier: 07640173232704
• UDI-Public: 010764017323270423152EL017250430
• 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): 08/16/2024

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: 23152EL0
• 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: Not provided
• Initial Report FDA Received Date: 08/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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