MAUDE Adverse Event Report: TEOXANE SA RHA 2; HYALURONIC ACID DERMAL FILLER GEL

Lot Number	23101DL0
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Foreign Body Embolism (4439)
Date of Event	03/26/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
According to the received information, this case seems linked to a vascular skin occlusion.Vascular complications are rare serious side effects, although widely known and documented in the context of filler injections.They are related to the accidental injection of the product inside or close to a blood vessel, leading to its occlusion or compression, blocking the blood flow.If treated on time with an appropriate treatment, symptoms can be fully resolved without sequalae.If the vascular complication is not detected/diagnosed and treated timely, it can lead to a skin necrosis.The risk of such adverse reactions is mentioned in the instructions for use of teosyal products.The batch data was reviewed and found compliant to the applicable specifications.No element allows us to identify a defect in the quality and safety of this product.
Event or Problem Description
This case occured outside of the usa, in australia.The australian affiliate notified teoxane geneva of an adverse event on 19-mar-2024.A patient was injected with 0.5 ml of teosyal rha 2 in the lips.The same day, during the injection, the patient experienced blanching in the left upper lip.The capilari refill was analyzed and appeared to be superior to five seconds.The injector diagnosed the symptoms as a vascular occlusin of moderate intensity, and a firm massage was done, but no improvement was observed.Therefore, the injector treated the patient with hyaluronidase on the upper lip.Following this treatment, all the filler was dissolved, and the patient completely recovered.  the complaint was considered closed.

• Brand Name: RHA 2
• Common Device Name: HYALURONIC ACID DERMAL FILLER GEL
• Manufacturer (Section D): TEOXANE SA; rue de lyon 105; geneva, 1203 ; SZ 1203
• Manufacturer Contact: omar mounir ; rue de lyon 105; geneva, 1203 ; SZ 1203
• MDR Report Key: 18959514
• Report Number: 3005975625-2024-00184
• Device Sequence Number: 9346023
• Product Code: LMH
• UDI-Device Identifier: 07640173230021
• UDI-Public: 01076401732300211023101DL017240531
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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): 03/22/2024

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 Lot Number: 23101DL0
• 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: 03/19/2024
• Initial Report FDA Received Date: 03/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/31/2023
• 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: Female