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

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.

• Brand Name: TEOSYAL RHA 3
• Type of Device: HYALURONIC 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 Key: 9290944
• MDR Text Key: 167568898
• Report Number: 3005975625-2019-00023
• Device Sequence Number: 1
• Product Code: LMH
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: P170002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 11/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2019
• Device Model Number: NOT APPLICABLE
• Device Catalogue Number: NOT APPLICABLE
• Device Lot Number: TP27L-173511A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/28/2019
• Initial Date FDA Received: 11/07/2019
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other