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

Model Number NOT APPLICABLE

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

Patient Problems Edema (1820); Pain (1994); 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 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.Batchs' analyses undertaken confirm that the products passed sterility and quality compliance tests, therefore the imputability of the products 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 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

The present incident happened outside of the u.S., in (b)(6).According to the received information, after the injection of teosyal rha 4 in the naso-labial folds, the patient presented with a severe adverse reaction.The treatment was 17th of february.The day after the patient complained a really severe pain to the nose.The doctor immediately visited her and detected severe monolateral erythema, redness and oedema.Following this initial assessment, a medical expert was consulted in order to assess the situation, and diagnosed a vascular compromise of the injected areas.According to the received information, the injector prescribed antibiotics, cortisone and aspirin.A medical expert was also consulted in order to provide treatment advices.His advices included immediate highdose hyaluronidase (1500ui) in the naso-labial fold and the nose, as well as local disinfection.This was done by the injector following those advices.Additional treatment advices includes led/pulsating light treatment as well as laser sessions to treat the remaining symptoms.According to the latest received information, the resolution of the symptoms is total.

• Brand Name: TEOSYAL RHA 4
• 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; same as contact office
• Manufacturer Contact: nicolas caill ; rue de lyon 105; geneva, CH-12-03 ; SZ CH-1203
• MDR Report Key: 10019990
• MDR Text Key: 193302786
• Report Number: 3005975625-2020-00011
• 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: 05/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/04/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2021
• Device Model Number: NOT APPLICABLE
• Device Catalogue Number: NOT APPLICABLE
• Device Lot Number: TPUL-193712B
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/19/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/30/2019
• 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