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

Lot Number	TPUL-23152EL0
Medical Device Problem Codes	Off-Label Use (1494); Use of Device Problem (1670)
Health Effect - Clinical Codes	Embolism/Embolus (4438); Foreign Body Embolism (4439)
Date of Event	04/30/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
This case occured outside the usa, in spain.On 10-may-2024, the spanish subsidiary notified us of an adverse event.According to the information received, a patient was injected on (b)(6) 2024 with 0.15ml of teosyal rha 4 in the nose (0.1ml in the nasal bone and 0.05ml in the columella).Immediately after the injections, on (b)(6) 2024, the patient presented with a whitening of the left nasal wing.The injector applied directly 3 cycles of hyaluronidase, 300 iu every half hour, and dry heat.The area has reperfused.The injector requested control photos after 3 days ; the photos were normal.On (b)(6) 2024, 9 days after the injections, the patient presented with vesicles in the area of the nasal bone and white lip.The patient also reported that the upper lip and the inner mucosa had wounds.She didn't contact the injector sooner as she thought it was herpes.Therefore, on (b)(6) 2024, the injector treated again the area with 2 cycles of hyaluronidase injections 300iu and prescribed antibiotic (amoxicillin 500mg every 8 hours).On (b)(6) 2024 the patient received additional injections of hyaluronidase (500iu).Additionally a medical assistance was provided.The local medical expert recommended to make an appointment on (b)(6) 2024 to see the evolution.On 23-may-2024, we were informed that the adverse events has resolved, and the patient was well without issue.The complaint was considered 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 teosyal products.Additionally, teosyal rha 4 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, geneva 1203 ; SZ 1203
• Manufacturer Contact: juliette vtrangos ; rue de lyon 105; geneva, geneva 1203 ; WZ 1203
• MDR Report Key: 19381084
• Report Number: 3005975625-2024-00332
• Device Sequence Number: 3727425
• Product Code: LMH
• UDI-Device Identifier: 07640173232704
• UDI-Public: 01076401732327041023152EL017300425
• 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): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/23/2024

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: 04/30/2025
• Device Lot Number: TPUL-23152EL0
• 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: 05/10/2024
• Initial Report FDA Received Date: 05/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/30/2023
• 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: 47 YR
• Patient Sex: Female