MAUDE Adverse Event Report: TEOXANE SA TEOSYAL RHA 2; IMPLANT, DERMAL, FOR AESTHETIC USE

Model Number	NOT APPLICABLE
Health Effect - Clinical Codes	Embolism/Embolus (4438); Foreign Body Embolism (4439)
Date of Event	11/03/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
This case occurred in the united states.According to the information received, a patient was injected on an unknown exact date in (b)(6) 2022, in the tear troughs with a rha 2 product.A total of 1ml of rha 2 was injected, 0.5 cc to each eye.On the day of the injection, the patient experienced partial ocular occlusion at the tear troughs, as well as blanching underneath the eye, towards the medial tear trough.There was no vision change and no pain.As corrective treatments, the patient received asa, heat, massage, nitropaste and hyaluronidase.On the same day the patient was also sent to the hospital where she received hyperbaric oxygen treatment for 5 days.At the time of this report, the event was resolving.No further information was received.
Additional Manufacturer Narrative
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.Although the visual symptoms could not be confirmed in this case, visual disorders symptoms are also rare but largely documented in the literature.They are typically linked to an intra-arterial injection of filler, which can result in an embolisation of the ophtalmic artery.They may also be unrelated to the use of dermal filler product.If treated with appropriate medical treatment, symptoms can be fully resolved without sequalae.Additionally, the risk of such adverse event is also mentioned in the instructions for use of teosyal products.
Event or Problem Description
This case occurred in the united states.According to the information received, a patient was injected on an unknown exact date in nov-2022, in the tear troughs with a rha 2 product.A total of 1ml of rha 2 was injected, 0.5 cc to each eye.On the day of the injection, the patient experienced partial ocular occlusion at the tear troughs, as well as blanching underneath the eye, towards the medial tear trough.There was no vision change and no pain.As corrective treatments, the patient received asa, heat, massage, nitropaste and hyaluronidase.On the same day the patient was also sent to the hospital where she received hyperbaric oxygen treatment for 5 days.At the time of this report, the event was resolving.No further information was received.

• Brand Name: TEOSYAL RHA 2
• Common Device Name: IMPLANT, DERMAL, FOR AESTHETIC USE
• Manufacturer (Section D): TEOXANE SA; 105 rue de lyon; 105; geneva, 1203 ; SZ 1203
• Manufacturer Contact: ornella fauconnot ; 105 rue de lyon; 105; geneva, 1203 ; SZ 1203 ; 022344-9636
• MDR Report Key: 15904960
• Report Number: 3005975625-2022-00704
• Device Sequence Number: 5126456
• Product Code: LMH
• UDI-Device Identifier: 07640173230021
• UDI-Public: 07640173230021
• 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: 2022
• 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): 05/04/2023

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 Model Number: NOT APPLICABLE
• Device Catalogue Number: NOT APPLICABLE
• Device Lot Number: TP30L-213512A0
• 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: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/02/2022
• Supplement Report FDA Received Date: 05/04/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Patient Race: White