• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

TEOXANE SA TEOSYAL RHA 4 HYALURONIC ACID DERMAL FILLER GEL Back to Search Results
Model Number N/A
Device Problem Patient-Device Incompatibility (2682)
Patient Problem Vascular System (Circulation), Impaired (2572)
Event Date 05/31/2020
Event Type  Injury  
Manufacturer Narrative
On (b)(6) 2020, the injector noticed a white area after injection and decided to injected 1 vial of hyaluronidase and informed the patient to keep an eye of it. 2 days later, the patient reported that she has white spots on her nose. As the injector suspected a vascular occlusion, the patient came back immediately to the surgery. The injector used hyaluronidase 4 times more and prescribed antibiotics (flucloxacillin 500 mg) and an ointment (chloramphenicol). 2 days after, symptoms were slowly subsiding but as the patient was worried, she went to the hospital where they gave her a drip. Kept her 2 days and then she was discharged. A full analysis of the related batch records of the products has being conducted to test for specification and sterility compliance. Results show that these products are compliant with the applicable specifications. No element allows us to identify a defect in the quality, sterility or safety of our products. 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. - 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 adverse event occurred outside of the us, in (b)(6). According to the received information, the patient was injected with teosyal rha 4 on (b)(6) 2020. The same day, the patient presented a purple coloration of the nose until the glabella. The injector suspected a vascular complication. The issue is now completely resolved.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameTEOSYAL RHA 4
Type of DeviceHYALURONIC ACID DERMAL FILLER GEL
Manufacturer (Section D)
TEOXANE SA
rue de lyon, 105
geneva, CH-12 03
SZ CH-1203
Manufacturer Contact
ornella rousseaux
rue de lyon, 105
geneva, CH-12-03
SZ   CH-1203
MDR Report Key10372910
MDR Text Key202003516
Report Number3005975625-2020-00023
Device Sequence Number1
Product Code LMH
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
170002
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 08/06/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/06/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date06/30/2021
Device Model NumberN/A
Device Catalogue NumberN/A
Device Lot NumberTPUL-192621B
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/07/2020
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 08/06/2020 Patient Sequence Number: 1
-
-