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

Lot Number	TPUL-22162FL0
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Granuloma (1876)
Date of Event	05/17/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
This event occured outside of the usa, in spain.On 01-oct-2024, the spanish subsidiary notified teoxane geneva of an adverse event.  according to the information received on 01-oct-2024, a patient was injected on (b)(6) 2023 with: - 2,4 ml of puresense ultra deep in cheekbones with a bolus technique and a cannula (rc/2410006) - 1,2 ml of rha 4 in the cheeks and marionette lines with a retrotracing technique (current complaint).Approximately 11 months after the injection, on (b)(6)n2024, the patient reported a mild oedema in the right tear trough.The same day, the patient received the following treatments: antibiotic treatment (doxycycline - 100mg/12 hours - 10 days) - glucocorticoid treatment (zamene - 15mg with a decreasing dose along time - unspecified duration).8 days after the last consultation, on (b)(6) 2024, the patient presented inflammatory nodules in marionette lines linked to the rha 4 injection (current complaint).During the consultation, the patient provided an ultrasound report that mentioned a reaction to a foreign body.The injector decided to dissolve the filler in the right tear trough and marionette lines with 100ui of hyaluronidase and the on-going treatment was maintained.  according to the information received on 02-oct-2024, a patient follow-up has been done and the symptoms were resolved, so the case was closed.
Additional Manufacturer Narrative
This case seems to be linked to a granulomatous reaction based on the ultrasound report.Granulomas that appear weeks to years after injection are known and widely documented reactions in the context of hyaluronic acid filler injections.They are caused by a delayed immune reaction in response to the filler, which is treated as a foreign body.Patient predisposition, trauma, vaccines, or infections are possible etiologies for this complication.Immune cells (macrophages) surround the product, inducing a destructive fibrotic process.Adequate treatment generally allows for a quick and effective resolution of these reactions, although certain granulomas at an advanced stage might be unresponsive to hyaluronidase.The risk of such reactions is mentioned in the instructions for use of products.

• 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: anaïs moreau
• MDR Report Key: 20425842
• Report Number: 3005975625-2024-00590
• Device Sequence Number: 7589970
• Product Code: LMH
• UDI-Device Identifier: 07640173232704
• UDI-Public: 0107640173232704102
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/11/2024

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: 04/30/2024
• Device Lot Number: TPUL-22162FL0
• 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: 09/27/2024
• Initial Report FDA Received Date: 10/11/2024
• 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: Unknown