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U.S. Department of Health and Human Services

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

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TEOXANE SA TEOSYAL RHA 3 HYALURONIC ACID DERMAL FILLER GEL, Back to Search Results
Model Number NOT APPLICABLE
Device Problems Contamination (1120); Migration or Expulsion of Device (1395); Patient-Device Incompatibility (2682)
Patient Problems Bacterial Infection (1735); Granuloma (1876); Skin Inflammation (2443)
Event Date 08/12/2019
Event Type  Injury  
Manufacturer Narrative
Clinical assessment revealed that nodules and indurations are well known and documented adverse reactions in the context of hyaluronic acid-based fillers injections. They may have several origins, including poor filler placement, filler migration (especially for a very mobile anatomical area, such as the lips), overcorrection, infection or immune mediated reaction. 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. Heydenrych i, kapoor km, de boulle k, goodman g, swift a, kumar n, rahman e. A 10-point plan for avoiding hyaluronic acid dermal filler-related complications during facial aesthetic procedures and algorithms for management. Clin cosmet investing dermatol. 2018 nov 23;11:603-611.
 
Event Description
Patient received 2 ml teosyal rha 3 injection in comes from pt: (b)(6) 2018 and was pleased with the result. On comes from pt: (b)(6) 2019 the patient complains about a problem that was developing over one month: nodules and induration, bilaterally, little or no pain, no redness, but continuing to emlarge without ceasing. The doctor who assessed the patient confirmed the presence of closed nodules, no rennets and very visible on mucous side, 25 cm lomg to hte right and 1. 5 cm long to the left, to the caudal extremity of sulcus gingivo labial. Aspiration done totally negative. No ganglion, no swelling around nodules. As the patient had recently dental treatment (date unknown), the doctor concluded in an infection by contamination on mucous perforation. A second medical assesment has been conducted by a medical expert who concluded in an allergic reaction according to patient hyperactive immune system and advised the prescription of systemis steroids by her physician. On 2019-09-05 the following update has been received: "the patient has been taken under a plastic surgeon care and her condition was improving day to day". No further follow up has been received since then despite several attempts. Clarion.
 
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Brand NameTEOSYAL RHA 3
Type of DeviceHYALURONIC ACID DERMAL FILLER GEL,
Manufacturer (Section D)
TEOXANE SA
rue de lyon, 105
geneva, 1203
SZ 1203
Manufacturer Contact
emilie macé
rue de lyon, 105
geneva, 1203
SZ   1203
MDR Report Key9290944
MDR Text Key167568898
Report Number3005975625-2019-00023
Device Sequence Number1
Product Code LMH
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
P170002
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Reporter Occupation
Type of Report Initial
Report Date 11/07/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/07/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date08/31/2019
Device Model NumberNOT APPLICABLE
Device Catalogue NumberNOT APPLICABLE
Device Lot NumberTP27L-173511A
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 Received08/28/2019
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? Yes
Type of Device Usage Initial

Patient Treatment Data
Date Received: 11/07/2019 Patient Sequence Number: 1
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