MAUDE Adverse Event Report: Teoxane SA RHA 4 Mepi; Hyaluronic Acid Dermal Filler Gel

Lot Number	25402IL0
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Abscess (1690)
Date of Event	08/05/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Abscess / discharged purulent material / pustula formed over area "[abscess]".Rha 4 in the chin "[off label use]".A trauma caused tenderness and pain "[pain]".Case narrative: on 26-aug-2026, primevigilance from usa notified teoxane geneva of an adverse event.The case was reported by the injector.According to the reporter, a female patient was injected on (b)(6) 2026 with 1 syringe of rha 4 in the chin using a needle and a needle-to-bone injection technique.The patient had a history of previous aesthetic procedures in the chin performed by another injector: restylane defyne on (b)(6) 2025, restylane lyft on (b)(6) 2025, rha 4 on (b)(6) 2025, relevant medical history included a treatment with an immunosuppressant.Around (b)(6) 2026, the patient had a trauma to the chin after being headbutted by a child, resulting in tenderness and pain in the area.On (b)(6) 2026, the patient received two hyaluronidase treatments to dissolve the filler (reason why not provided).At this time, an abscess was noticed by the injector, and an antibiotherapy was prescribed.According to the injector, it remained unclear whether the trauma triggered the subsequent abscess.On (b)(6) 2026, a pustule appeared over the affected area and spontaneously drained purulent material.The drainage gradually subsided over the following two to three days, and the symptoms resolved.Approximately two weeks later, the symptoms worsened.The patient went to the emergency department, where incision and drainage were performed.At the time of the latest information received, the patient was awaiting a two-week follow-up with an infectious disease specialist.Based on the available information and the medical intervention required to drain the abscess, the event was assessed as reportable.At the time of this report, the patient's symptoms are being monitored and the investigations are still on-going.
Additional Manufacturer Narrative
According to the information received, this case seems to be linked to an abscess.Skin infections such as abscess, are well-known and widely documented adverse reactions in the context of hyaluronic acid filler injections.Infections are usually caused by an association of multiple bacteria that invade the wound at the site of injection due to a temporary disruption of the skin barrier (in this case possibly caused by patient trauma).Adequate treatment with antibiotics leads to a complete resolution of the symptoms without sequelae.Additionally, the risk of such adverse events is mentioned in the instructions for use of teosyal products.Based on the unsuggestive temporal relationship, and the possible alternative etiology from the trauma, the relatedness of the symptoms with the injection of rha 4 has been assessed at this stage as not related for the pain and possible for the abscess.Of note, rha 4 is not indicated for the chin in the usa.This is default text configured for block h10.

• Brand Name: RHA 4 Mepi
• Common Device Name: Hyaluronic Acid Dermal Filler Gel
• Manufacturer (Section D): Teoxane SA; rue de lyon 105; geneva 1203 ; SZ 1203
• Manufacturer (Section G): Teoxane SA; rue de lyon 105; geneva 1203 ; SZ 1203
• MDR Report Key: 50880062
• Report Number: 3005975625-2026-00055
• Device Sequence Number: 13431931
• Product Code: LMH
• UDI-Device Identifier: 07640173233480
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P170002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Nurse Practitioner
• Type of Report: Initial
• Report Date (Section B): 09/24/2026

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 Lot Number: 25402IL0
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/26/2026
• Initial Report FDA Received Date: 09/24/2026
• 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; Required Intervention
• Patient Sex: Female