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U.S. Department of Health and Human Services

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

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TEOXANE SA TEOSYAL RHA 2 HYALURONIC ACID DERMAL FILLER GEL Back to Search Results
Model Number NOT APPLICABLE
Device Problem Obstruction of Flow (2423)
Patient Problem Vascular System (Circulation), Impaired (2572)
Event Date 03/18/2020
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 analyses undertaken confirms that the product passed sterility and quality compliance tests, therefore the imputability of the product 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
This event happened outside of the u. S. , in (b)(6). According to the received information, on the same day as the use of teosyal rha 2 in the nasolabial folds, the patient presented with an intravascular occlusion.
 
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Brand NameTEOSYAL RHA 2
Type of DeviceHYALURONIC 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
Manufacturer Contact
nicolas
rue de lyon, 105
geneva, CH-12-03
MDR Report Key10042767
MDR Text Key190513639
Report Number3005975625-2020-00012
Device Sequence Number1
Product Code LMH
Combination Product (y/n)N
PMA/PMN Number
P170002
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Type of Report Initial
Report Date 05/11/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/11/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date08/31/2021
Device Model NumberNOT APPLICABLE
Device Catalogue NumberNOT APPLICABLE
Device Lot NumberTP30L-193515C
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/20/2020
Was Device Evaluated by Manufacturer? No
Date Device Manufactured08/31/2019
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: 05/11/2020 Patient Sequence Number: 1
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