MAUDE Adverse Event Report: TEOXANE SA TEOSYAL RHA 4 HYALURONIC ACID DERMAL FILLER GEL

Model Number N/A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Vascular System (Circulation), Impaired (2572)

Event Date 02/19/2020

Event Type  Injury  

Manufacturer Narrative

According to the received investigation, this case seems to be a vascular complication following the injection of the product, which is a well-known adverse reaction due to an accidental injection in or near a vessel, triggering its compression or occlusion. Batch analyses undertaken confirms that the products passed sterility and quality compliance tests, therefore the imputability of the product seems dismissed. Vascular compromises are serious adverse events that are well known and well-documented related to the injection of hyaluronic acid fillers. They are linked to an accidental injection in, or next to a vessel, triggering its compression or occlusion. If treated on time with an appropriate treatment, symptoms can be fully resolved, without sequalae. If not, they can worsen and develop into skin necrosis. Additionally, the risk of such adverse event is also mentioned in the instructions for use of teosyal products. - de boulle k, heydenrych i. Patient factors influencing dermal filler complications: prevention, assessment, and treatment. Clin cosmet investig dermatol. 2015;8:205-14 - signorini, m. , et al. (2016). "global aesthetics consensus: avoidance and management of complications from hyaluronic acid fillers-evidence- and opinion-based review and consensus recommendations. " plastic and reconstructive surgery 137(6):961e-971e - delorenzi, c. (2014). "complications of injectable fillers, part 2: vascular complications. " aesthetic surgery journal / the american society for aesthetic plastic surgery 34(4): 584-600.

Event Description

The event occurred outside of the us, in (b)(6). According to the received information, the patient was injected with 0,15 ml of teosyal rha 4 in the nose on (b)(6) 2020; less than 0,1 ml in the nose and almost 1 ml in the nasolabial folds on (b)(6) 2020. On (b)(6) 2020 in the morning, the patient complained about a sudden pain in the nose and an oedema. The patient did not come on consultation this day. On (b)(6) 2020, the patient came to the clinic. His clinical state was reassuring despite of the pictures taken this day. He also had a good capillary pulse. On (b)(6) 2020, during the follow-up consultation, the injector noticed that the redness had worsened and the edema and pain of moderate intensity remained on the paranasal area. The capillary pulse was still present. The patient then received 2 hyalase injections. A clear improvement of the symptoms was noticed after the second hyalase injection. The patient was last seen at the clinic on (b)(6) 2020, there was a good evolution of the symptoms, the redness had decreased significantly but a residue remained. The injector advised to apply a cortisone cream and a solar protection. Since that day, the patient decided to stop the management of his symptoms by the clinic. According to the received information on 2020-05-05 and 2020-05-18, the nature of the adverse event reported was unclear for the injector. A medical expert has been consulted on (b)(6) 2020 in order to assess the case and diagnosed a vascular embolism of the injected area.

• Brand Name: TEOSYAL RHA 4
• Type of Device: HYALURONIC ACID DERMAL FILLER GEL
• Manufacturer (Section D): TEOXANE SA; rue de lyon; geneva, CH-12 03; SZ CH-1203
• Manufacturer Contact: ornella rousseaux ; rue de lyon, 105; geneva, CH-12-03 ; SZ CH-1203
• MDR Report Key: 10200385
• Report Number: 3005975625-2020-00014
• Device Sequence Number: 1
• Product Code: LMH
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: P170002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional

Reporter Occupation

• Type of Report: Initial
• Report Date: 06/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/26/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Expiration Date: 05/31/2021
• Device Model Number: N/A
• Device Catalogue Number: N/A
• Device Lot Number: TPUL-191822A
• Was Device Available for Evaluation?: No

Is the Reporter a Health Professional?

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 05/05/2020
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/26/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Initial
• Patient Age: 44 YR
• Patient Outcome(s): Other