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

Lot Number	TPUL-23392CL0
Medical Device Problem Codes	Off-Label Use (1494); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Codes	Necrosis (1971); Foreign Body Embolism (4439)
Date of Event	05/01/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
This event occured outside of the usa, in italy.The italian subsidiary notified teoxane of an adverse event on 06-may-2024.A patient was injected on (b)(6) 2024 with a total of 0.4 ml of rha 4 in the nose (0.2 ml on the tip and 0.2 ml in the nasal spine).The injections were done with the bolus technique using the needle provided in the box.2 days after the injection, on (b)(6) 2024, the patient experienced hypoperfusion accompanied by epidermolysis on the right nasal wing.The patient was treated with hyaluronidase: on (b)(6) 2024 800 i.U.On (b)(6) 2024 700 i.U.On (b)(6) 2024, the injector contacted the local medical expert, who diagnosed the symptoms as necrosis.In agreement with the medical expert, the patient was further treated with hyaluronidase as follows: on (b)(6) 2024 600 i.U.On (b)(6) 2024 450 i.U.On (b)(6) 2024 300 i.U.In addition, the patient was prescribed the following treatments: antibiotic (augmentin 2 tbt for 5 days) corticoid (bentelan, 4 g, 2 times a day) non-steroid anti-inflammatory drug (aspirine 500 mg, 2 times a day) proton pump inhibitor (pantorc 40 mg once a day for 10 days) from (b)(6) 2024, the patient also applied topical therapy to promote healing (intrasite gel and promogran).On (b)(6) 2024, we were informed that the symptoms had almost fully resolved.Only a slight redness remained.The patient was only continuing to apply the topical therapy.According to the resolution of the symptoms, the case was closed.
Additional Manufacturer Narrative
Vascular complications are rare and serious side effects, although they are widely known and documented in the context of dermal filler injections.They are related to the accidental injection of the product inside a blood vessel, leading to its occlusion.The local deprivation of blood supply causes tissue anoxia.If enough hyaluronidase is injected on time, symptoms can be fully resolved without sequalae.If the vascular complication is not detected, diagnosed, and treated promptly, it can lead to skin necrosis.The risk of such adverse reactions is mentioned in the instructions for use of rha 4 products.Additionally, this teosyal product is not indicated for this area.Therefore, this constitutes an off-label use for which the safety and performance of the product cannot be guaranteed.

• Brand Name: RHA 4
• Common Device Name: HYALURONIC ACID DERMAL FILLER
• Manufacturer (Section D): TEOXANE SA; rue de lyon 105; geneva, 1205 ; SZ 1205
• Manufacturer Contact: morgane burgisser
• MDR Report Key: 19457113
• Report Number: 3005975625-2024-00318
• Device Sequence Number: 18119569
• Product Code: LMH
• UDI-Device Identifier: 07640173232704
• UDI-Public: 01076401732327041023392CL017250930
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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): 06/04/2024

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: 09/30/2025
• Device Lot Number: TPUL-23392CL0
• 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: 05/06/2024
• Initial Report FDA Received Date: 06/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/30/2023
• 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: Male