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

Lot Number	102326FL0
Medical Device Problem Codes	Off-Label Use (1494); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Skin Infection (4544)
Date of Event	06/08/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Primevigilance notified teoxane of an adverse event on 18-jun-2024.The patient was injected on (b)(6) 2024 with 1 ml of rha 4 in the mid-cheek using an unspecified needle.On the same day, the patient also received botulinum toxin (xeomin) at an unspecified site.The day after the injection, on (b)(6) 2024, the patient went to the er and was hospitalized for 2 days, from (b)(6) 2024 to (b)(6) 2024, due to puffy eyes and swollen lips and cheeks.It was noted that the swelling in the left cheek was "10 times" worse than the right cheek.An allergic reaction was first diagnosed.In the meantime, a ct scan was performed on (b)(6) 2024 and showed fluid accumulation.The patient was prescribed steroids and an oral antibiotic on an unspecified date as treatment.And on (b)(6) 2024 hyaluronidase (hylenex) was injected under ultrasound guidance.According to the reporter, this procedure exacerbated the swelling.On (b)(6) 2024, the patient was readmitted to the hospital.A cat scan performed on the same day showed fluid accumulation.According to the injector, an infection was then suspected.The infectious disease service was consulted, and the patient received antibiotics intravenously.The discharge date from the hospital was not specified.The patient planned to have filler dissolved by her injector on (b)(6) 2024, but there was no confirmation of the visit or the outcome of the procedure.The patient had known allergy to non-steroidal drugs.The lidocaine test performed on the forearm was negative.This was the patient's first treatment with a filler.On (b)(6) 2024, we were informed that the patient's symptoms were resolving, thus the case was closed.A second patient with similar symptoms was mentioned (case (b)(4) ), but no further information could be retrieved to confirm the exact symptoms, thus the case was considered as non- reportable.
Additional Manufacturer Narrative
Skin infections may manifest as swelling and puffiness in and around the injection sites.They appear within days after injection.These 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.Lack of asepsis during injection and/or posttreatment care are common etiologies for this complication.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.It has to be noted that this case was first assessed as allergic reaction.However, considering the fact that the symptoms were significantly worse on the left side and exacerbated post hyalase treatment, an infection was later on suspected.Therefore, the relatedness of the allergic reaction with the injection of rha 4 was assessed as not assessable, and only a causal relationship between the rha 4 injection and infection was assessed as possible based on the symptoms, the suggestive temporal relationship, and the possible alternative etiology from botox injection for which no information could be retrieved on exact injection sites.Of note, rha 4 is not indicated for the cheeks in the us.

• 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: paulina pietrucha
• MDR Report Key: 19769065
• Report Number: 3005975625-2024-00401
• Device Sequence Number: 8920559
• Product Code: LMH
• UDI-Device Identifier: 07640173232704
• UDI-Public: 7640173232704
• 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: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/18/2024

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: 03/06/2025
• Device Lot Number: 102326FL0
• 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: 06/18/2024
• Initial Report FDA Received Date: 07/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/30/2025
• 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; Hospitalization
• Patient Sex: Female