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

Lot Number	TPUL-2403R4L0
Medical Device Problem Codes	Off-Label Use (1494); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Foreign Body Embolism (4439)
Date of Event	10/25/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
This case occured outside of the usa in spain.On 28-oct-2024, the spanish subsidiary notified teoxane geneva of an adverse event.According to the information received, a patient was injected on (b)(6) 2024 with 0.8 ml of rha 4 in the nose (0.3 ml in the tip of the nose, 0.5 ml in the upper part of the nose).8 days after the injection, on (b)(6) 2024, the patient experienced erythema and ulceration on the tip of the nose, both of severe intensity, and a possible necrosis of tissue in the tip of nose.A medical expert was contacted for guidance who thought it was a vascular compromise due to hyaluronic acid compression and recommended to inject hyaluronidase, to prescribe an analgesic treatment (adiro) and a treatment cream for skin lesion (topical mupirocin).9 days after the injection, on (b)(6) 2024 the patient was injected with 2500 units of hyaluronidase, and a follow-up appointment was scheduled for the week after.According to the information received on 12-nov-2024, the injector removed the filler with hyaluronidase and prescribed a prototypical analgesic treatment (adiro) and topical mupirocin to the patient.The injector confirmed the case was closed; thus, the case was closed on our side.
Additional Manufacturer Narrative
According to the information received, the case seemed to be linked to a vascular compromise due to hyaluronic acid compression 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, or to a high amount of product injected near a vessel, leading to its compression.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 products.Additionally, this product is not indicated for this area (nose).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, 1203 ; SZ 1203
• Manufacturer Contact: céline vial
• MDR Report Key: 20770083
• Report Number: 3005975625-2024-00643
• Device Sequence Number: 11837534
• Product Code: LMH
• UDI-Device Identifier: 07640173232704
• UDI-Public: 0107640173232704102403R4L017251230
• 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): 11/25/2024

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: 12/30/2025
• Device Lot Number: TPUL-2403R4L0
• 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: 10/25/2024
• Initial Report FDA Received Date: 11/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/30/2023
• 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 Age: 32 YR
• Patient Sex: Female