MAUDE Adverse Event Report: TEOXANE SA RHA 3; HYALURONIC ACID DERMAL FILLER

Lot Number	SEE B6
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Foreign Body Embolism (4439)
Date of Event	07/12/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Primevigilance notified teoxane of an adverse event on (b)(6) 2024.The patient was injected with rha 3 in the nasolabial folds on (b)(6) 2024.The injection was administered with an unspecified needle.Two days after the injection, on (b)(6) 2024, the patient exhibited redness and a pustule around the left nasolabial fold at the injection site.As a treatment, the injector prescribed an antibiotic (doxycycline, 100 mg), and an unknown quantity of hyaluronidase was administered by a different provider.On (b)(6) 2024 we were informed that the symptoms were resolving.According to the patient's medical history, she had a history of acne and has suffered from breast cancer.Due to the limited information received and the potential seriousness of the events erported, on (b)(6) 2024, theteoxane's medical expert was contacted to provide a diagnosis.According to him, the events reported and pictures would be compatible with a vascular occlusion.Therefore, the case was upgraded as reportable to the fda.At the time of this report, no additional information is available, but the situation and symptoms remain monitored.
Additional Manufacturer Narrative
The symptoms are monitored and additional information will be added to final report.
Event or Problem Description
Primevigilance notified teoxane of an adverse event on (b)(6) 2024.The patient was injected with rha 3 in the nasolabial folds on (b)(6) 2024.The injection was administered with an unspecified needle.Two days after the injection, on (b)(6) 2024, the patient exhibited redness and a pustule around the left nasolabial fold at the injection site.As a treatment, the injector prescribed an antibiotic (doxycycline, 100 mg), and an unknown quantity of hyaluronidase was administered by a different provider.On (b)(6) 2024 we were informed that the symptoms were resolving.According to the patient's medical history, she had a history of acne and has suffered from breast cancer.Due to the limited information received and the potential seriousness of the events reported, on (b)(6) 2024, the teoxane's medical expert was contacted to provide a diagnosis.According to him, the events reported and pictures would be compatible with a vascular occlusion.Therefore, the case was upgraded as reportable to the fda.Despite reminders, no updates were provided, thus the case was closed as is.
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 or close to a blood vessel, leading to its occlusion or 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.

• Brand Name: RHA 3
• 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: 19970663
• Report Number: 3005975625-2024-00464
• Device Sequence Number: 8966585
• Product Code: LMH
• UDI-Device Identifier: 07640173230045
• UDI-Public: 7640173230045
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/23/2024

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 Lot Number: SEE B6
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/15/2024
• Supplement Date Received by Manufacturer: 07/15/2024
• Initial Report FDA Received Date: 08/13/2024
• Supplement Report FDA Received Date: 08/23/2024
• 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