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

Lot Number TPUL-193712A / TPUL-194311A

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

Patient Problems Unspecified Infection (1930); Skin Inflammation (2443)

Event Date 06/20/2020

Event Type  Injury  

Manufacturer Narrative

Delayed inflammatory reactions that manifest as nodules, are well-known and documented reactions in the context of hyaluronic acid dermal filler injections.They can be linked to an immune response of the organism to the implant or to a bacterial infection.Their risk of occurrence is increased in an infectious context, and in this case probably exacerbated by the chronic sinusitis and episode of previous inflammatory reaction of sinuses reported by the patient.With medical treatment, symptoms can be quickly fully resolved, without sequelae.In addition, the risk of such reaction is mentioned in the instructions for use of teosyal 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.Kim j h, ahn d k, jeong h s, suh i s.Treatment algorithm of complications after filler injection: based on wound healing process.J.Korean med sci.2014 ; 29/suppl 3) : s176 - s182.

Event Description

This event happened outside of the u.S., in (b)(6).According to the received information , the patient was injected with teosyal rha 4: in the nasolabial folds and in the marionettes lines on (b)(6) 2020.In the marionettes lines and in each cheek on the (b)(6) 2020.The following information about the symptoms have been transmitted to teoxane on the 2020-07-31: on (b)(6) 2020, the patient presented inflammatory visible and palpable nodules on all the areas injected, a swollen and red oral mucosa.On the (b)(6) 2020 the patient presented to the injector who diagnosis the development of inflammatory nodules and a biofilm infection.Steroids injections (dexaven) and oral antibiotics (clarithromycin) have been implemented immediately 24h after the treatment, the patient's condition improved, swelling and nodules decreased.7 days later the patient's condition continues to improve event thought nodules were still present.According to the latest news received on 26.08.2020, the patient was "ok and in a good condition" the patient suffers of chronic sinusitis.She also reported previous inflammatory process of maxillary sinuses, nasal obstruction and nasal damage.

• Brand Name: TEOSYAL RHA 4
• Type of Device: HYALURONIC ACID DERMAL FILLER GEL
• Manufacturer (Section D): TEOXANE SA; rue de lyon, 105; geneva, ; SZ
• 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: 10459105
• MDR Text Key: 205113007
• Report Number: 3005975625-2020-00025
• 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: 08/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 09/30/2021
• Device Lot Number: TPUL-193712A / TPUL-194311A
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/29/2020
• Initial Date FDA Received: 08/27/2020
• Was Device Evaluated by Manufacturer?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1