MAUDE Adverse Event Report: TEOXANE SA TEOSYAL RHA 3; HYALURONIC ACID DERMAL FILLER GEL

Lot Number TP27L-192711B

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

Patient Problems Necrosis (1971); Vascular System (Circulation), Impaired (2572)

Event Date 12/20/2019

Event Type  Injury  

Manufacturer Narrative

According to the received information, 2 days following the injection of the product in the nose, the patient presented with necrosis, small vesicles on the tip of the nose with moderate pain.3 weeks after, symptoms are attenuated and are being resolved.The doctor injected hyaluronidase and performed a massage on the affected area.The doctor also prescribed aspirin (375mg, bid), neoviderm (cream) and fucidin (cream) at the date of this report the patient is under close medical monitoring.This incident happened outside the united states, in (b)(6).Our first assessment points out what seems to be that the necrosis appeared after the injection of the product in the treated areas.The doctor has been contacted to obtain more information on the initial diagnosis, the management of the adverse reaction and the improvement of the patient's symptoms.Furthermore, as the product had been injected in the patient, no product return will be performed.Vascular compronise occurring after injection are well-known and documented adverse reactions following injections of hyaluronic acid fillers.The risk of such effects is mentioned in the instruction for use of our product and are mentioned in the following publications: de boulle k, heydenrych i.Patient factors influencing dermal filler complications: prevention, assessment, and treatment.Clin cosmet investig dermatol.2015;8:205-14 http://www.Ncbi.Nlm.Nih.Gov/pubmed/25926750.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 https://www.Ncbi.Nlm.Nih.Gov/pubmed/27219265,.

Event Description

According to the received information, 2 days following the injection of the product in the nose, the patient presented with necrosis, small vesicles on the tip of the nose with moderate pain.3 weeks after, symptoms are attenuated and are being resolved.The doctor injected hyaluronidase and performed a massage on the affected area.The doctor also prescribed aspirin (375mg, bid), neoviderm (cream) and fucidin (cream) at the date of this report the patient is under close medical monitoring.

• Brand Name: TEOSYAL RHA 3
• Type of Device: HYALURONIC ACID DERMAL FILLER GEL
• Manufacturer (Section D): TEOXANE SA; 105 rue de lyon; geneva, CH-12 03; SZ CH-1203
• Manufacturer (Section G): SAME AS CONTACT OFFICE; same as contact office; same as contact office, CH-12 03; SZ CH-1203
• Manufacturer Contact: emile eichenlaub ; 105 rue de lyon; geneva, CH-12-03 ; SZ CH-1203
• MDR Report Key: 9611334
• MDR Text Key: 189636112
• Report Number: 3005975625-2020-00002
• Device Sequence Number: 1
• Product Code: LMH
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: P170002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Remedial Action: Patient Monitoring
• Type of Report: Initial
• Report Date: 01/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2021
• Device Lot Number: TP27L-192711B
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/23/2019
• Initial Date FDA Received: 01/21/2020
• 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): Required Intervention
• Patient Age: 34 YR