MAUDE Adverse Event Report: TEOXANE SA TEOSYAL RHA 2; HYALURONIC ACID DERMAL FILLER GEL

Model Number NOT APPLICABLE

Device Problem Obstruction of Flow (2423)

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

Event Date 03/18/2020

Event Type  Injury  

Manufacturer Narrative

According to the received investigation, this case seems to be a vascular compromise 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 product 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 sequelae.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 our products.Literature data: 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

This event happened outside of the u.S., in (b)(6).According to the received information, on the same day as the use of teosyal rha 2 in the nasolabial folds, the patient presented with an intravascular occlusion.

• Brand Name: TEOSYAL RHA 2
• Type of Device: HYALURONIC ACID DERMAL FILLER GEL
• Manufacturer (Section D): TEOXANE SA; rue de lyon, 105; geneva, CH-12 03; SZ CH-1203
• Manufacturer (Section G): SAME AS CONTACT OFFICE
• Manufacturer Contact: nicolas ; rue de lyon, 105; geneva, CH-12-03
• MDR Report Key: 10042767
• MDR Text Key: 190513639
• Report Number: 3005975625-2020-00012
• Device Sequence Number: 1
• Product Code: LMH
• Combination Product (y/n): N
• PMA/PMN Number: P170002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial
• Report Date: 05/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/11/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2021
• Device Model Number: NOT APPLICABLE
• Device Catalogue Number: NOT APPLICABLE
• Device Lot Number: TP30L-193515C
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/20/2020
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/31/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other