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

Lot Number	SEE B6
Medical Device Problem Codes	Off-Label Use (1494); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Codes	Embolism/Embolus (4438); Foreign Body Embolism (4439)
Date of Event	06/30/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Primevigilance notified teoxane of an adverse event on 03-jul-2024.A patient was injected with rha redensity into the forehead on (b)(6) 2024.The injection was administered very superficially using an unspecified needle.Two days after the injection, on (b)(6) 2024, the patient developed redness, with blisters and whiteheads on the forehead.The following day, on (b)(6) 2024, the redness appeared to darken.The injector suggested the possibility of vascular occlusion and injected hyaluronidase (hylenex) as a treatment.The situation of the patient and symptoms evolution are monitored.No additional information is available at the time of this report.
Additional Manufacturer Narrative
The symptoms are monitored and additional information will be added to final report.
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 products.Of note, rha redensity is not indicated in the forehead in the us.
Event or Problem Description
Primevigilance notified teoxane of an adverse event on 03-jul-2024.A patient was injected with rha redensity into the forehead on (b)(6) 2024.The injection was administered very superficially using an unspecified needle.Two days after the injection, on (b)(6) 2024, the patient developed redness, with blisters and whiteheads on the forehead.The following day, on (b)(6) 2024, the redness appeared to darken.The injector suggested the possibility of vascular occlusion and injected hyaluronidase (hylenex) as a treatment.Despite reminders, no updates were provided about the patient, thus the case was closed as is.

• Brand Name: RHA REDENSITY
• Common Device Name: HYALURONIC ACID DERMAL FILLER
• Manufacturer (Section D): TEOXANE SA; rue de lyon 105; geneva, 1203 ; SZ 1203
• Manufacturer Contact: paulina pietrucha ; SZ
• MDR Report Key: 19879957
• Report Number: 3005975625-2024-00438
• Device Sequence Number: 12562541
• Product Code: LMH
• UDI-Device Identifier: 07640173231653
• UDI-Public: 7640173231653
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/08/2024

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: SEE B6
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 07/03/2024
• Supplement Date Received by Manufacturer: 07/03/2024
• Initial Report FDA Received Date: 08/01/2024
• Supplement Report FDA Received Date: 08/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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