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U.S. Department of Health and Human Services

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

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TEOXANE SA TEOSYAL RHA 4 HYALURONIC ACID DERMAL FILLER GEL Back to Search Results
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.
 
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Brand NameTEOSYAL RHA 4
Type of DeviceHYALURONIC 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 Key10459105
MDR Text Key205113007
Report Number3005975625-2020-00025
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 08/27/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/27/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator
Device Expiration Date09/30/2021
Device Lot NumberTPUL-193712A / TPUL-194311A
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/29/2020
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Initial

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