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

Model Number NOT APPLICABLE

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

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

Event Date 07/15/2020

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's 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 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

The present incident happened outside of the united states, in (b)(6).According to the received information, on (b)(6) 2020 the patient was injected with teosyal rha 2 in the forehead center.On (b)(6) 2020 the patient presented, according the injector, redness and hematoma in the injected area.A medical expert was consulted in order to assess the situation, and diagnosed an embolisation of the injected area.According to the received information, the medical expert treated the symptoms with injection of hylase and a local antibiotic cream according to the latest received information, the symptoms are being solved, the medical expert mention that there could stay a minimal necrosis.

• 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; same as contact office
• Manufacturer Contact: fiona di folco ; rue de lyon 105; geneva, CH 12-03 ; SZ CH 1203
• MDR Report Key: 10332038
• MDR Text Key: 202694203
• Report Number: 3005975625-2020-00020
• Device Sequence Number: 1
• Product Code: LMH
• Combination Product (y/n): N
• PMA/PMN Number: 170002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial
• Report Date: 07/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/28/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 11/30/2021
• Device Model Number: NOT APPLICABLE
• Device Catalogue Number: NOT APPLICABLE
• Device Lot Number: 194725A0
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/16/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/30/2020
• 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 Age: 41 YR