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

Model Number NOT APPLICABLE

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problems Ecchymosis (1818); Embolism/Embolus (4438)

Event Date 12/06/2021

Event Type  Injury  

Manufacturer Narrative

Batch number of the related product has been retrieved and quality investigations performed.The batch has been released in accordance with the manufacturers' specifications.One other complaint has been registered for this batch number to date.This complaint is not related to the present complaint.

Event Description

According to the information received on (b)(6) 2021, a patient was injected in the nasolabial folds on (b)(6) 2021 with teosyal rha 3.Following injection, the patient developed an embolization.A local medical expert (b)(6) was then contacted the same day by our italian affiliate in order to help in the management of the case.Another doctor (dr trocchi) supported the injector to treat the issue since the latter did not have enough hyaluronidase in her ambulatory and a worsening occured in the evening.Dr trocchi used hyaluronidase immediately on (b)(6) 2021, and the day after, additional 200iu of hyaluronidase.However, on (b)(6) 2021, the situation was not improving, so the patient received a third hyaluronidase injection (100iu).The patient had an ultrasound (unknown date) which confirmed the presence of ecchymotic effusion in the malar region and right cheek with the presence of crusty evolution.On (b)(6) 2021, the patient received a fourth hyaluronidase injection (100iu).Despite reminders, we did not receive additional information regarding symptoms evolution or any update at the time of this report.

• Brand Name: TEOSYAL RHA 3
• Type of Device: DERMAL FILLER
• Manufacturer (Section D): TEOXANE SA; rue de lyon; 105; geneva 1203 ; CH 1203
• Manufacturer (Section G): TEOXANE SA; rue de lyon; 105; geneva 1203 ; CH 1203
• Manufacturer Contact: nicolas caill ; rue de lyon; 105; geneva 1203 ; CH 1203 ; 022344-963
• MDR Report Key: 13168707
• MDR Text Key: 284046644
• Report Number: 3005975625-2021-00743
• Device Sequence Number: 1
• Product Code: LMH
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: P170002,
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/05/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2023
• Device Model Number: NOT APPLICABLE
• Device Catalogue Number: NOT APPLICABLE
• Device Lot Number: TP27L-210722B0
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/28/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Female