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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TEOXANE SA TEOSYAL RHA 4/ TEOSYAL RHA 3 HYALURONIC ACID DERMAL FILLER GEL

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TEOXANE SA TEOSYAL RHA 4/ TEOSYAL RHA 3 HYALURONIC ACID DERMAL FILLER GEL Back to Search Results
Model Number NOT APPLICABLE
Device Problem Patient-Device Incompatibility (2682)
Patient Problems Granuloma (1876); Swelling (2091); Skin Inflammation (2443)
Event Date 06/29/2020
Event Type  Injury  
Manufacturer Narrative
A full analysis of the related batch was carried out to test for specification and sterility compliance. The analysis results showed full compliance to finished product specifications and sterility of the batch in question. Delayed inflammatory reactions that may manifest as swelling and nodules are well known and documented adverse reactions in the context of hyaluronic acid-based fillers injections. They may have several origins, including an immune response of the body against the implant (which may manifest as a granuloma), or a bacterial infection. These effects are usually of no consequence and of rapid resolution after appropriate medical treatment. In addition, the risk of such a reaction is mentioned in the instructions for use of our products. Bibliography: de boulle k, heydenrych i. Patient factors influencing dermal filler complications: prevention, assessment, and treatment. Clin cosmet investig dermatol. 2015;8:205-14. Funt d, pavicic t. Dermal fillers in aesthetics: an overview of adverse events and treatment approaches. Clin cosmet investig dermatol 2013;6:295-316. 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. Woodward, j. , et al. (2015). "facial filler complications. " facial plastic surgery clinics of north america 23(4): 447-458. Delorenzi, c. (2013). "complications of injectable fillers, part i. " aesthet surg j 33(4): 561-575.
 
Event Description
This incident happened outside of the united states, in (b)(6). According to the received information, on (b)(6) 2020, the patient was injected with rha4 (in the cheeks), and rha3 (cheeks wrinkles, chin and nasolabial folds). On 06. 30. 2020 the injector reported that the patient has developed hard lump, swelling and redness at all injection sites. An antibiotic was given by th injector and injection of hyaluronidase was recommended by a medical expert mandated by the canadian distributor. On 05. 07. 2020 the injector reported to the (b)(6) expert that the condition patient was getting worse. The photo showed an important swelling on the right cheek. The injector also asked if the injection of the hyaluronidase should be accompanied with oral prednisolone, which was confirmed by the canadian expert. According to the information received on the 24. 07. 2020, the patient's condition seems to be progressing well.
 
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Brand NameTEOSYAL RHA 4/ TEOSYAL RHA 3
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
same as contact office
Manufacturer Contact
fiona di folco
rue de lyon 105
geneva CH 12-03
SZ   CH 1203
MDR Report Key10326434
MDR Text Key202693567
Report Number3005975625-2020-00019
Device Sequence Number1
Product Code LMH
Combination Product (y/n)N
Reporter Country CodeSZ
PMA/PMN Number
P170002
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation
Type of Report Initial
Report Date 07/27/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/27/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date09/30/2020
Device Model NumberNOT APPLICABLE
Device Catalogue NumberNOT APPLICABLE
Device Lot NumberTPUL-183914A/TP27L-183725C
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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: 07/27/2020 Patient Sequence Number: 1
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