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

Model Number NOT APPLICABLE

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Edema (1820); Swelling (2091); Skin Inflammation (2443)

Event Date 11/07/2019

Event Type  Injury  

Manufacturer Narrative

Clinical assessment revealed that nodules, inflammation 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 investig dermatol.2018 nov 23;11:603-611.

Event Description

The event happened outside of the u.S., in (b)(6).According to the received information, three months after the injections, the patient presented with injection site masses, skin inflammation and skin induration in the injected areas (nose ans lips area).The reported intensity is moderate.Patient was initially treated with injection of hyaluronidase and oral steroids, as well as antihistamines without improvement at the time of the initial report.On the day after being informed of the complaint by the initial reporter, the patient went to the hospital for treatment advices.Iv steroids was prescribed as well as antihistamines, inducing an improvement of the symptoms.Following treatments to this date includes steroids and wobenzime, and according to the last information, the resolution of the symptoms is partial.

• Brand Name: TEOSYAL RHA 4
• Type of Device: HYALURONIC 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: nicolas caill ; rue de lyon, 105; geneva, CH-12-03 ; SZ CH-1203
• MDR Report Key: 9489650
• MDR Text Key: 187770059
• Report Number: 3005975625-2019-00031
• Device Sequence Number: 1
• Product Code: LMH
• Combination Product (y/n): N
• PMA/PMN Number: P170002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial
• Report Date: 12/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2020
• Device Model Number: NOT APPLICABLE
• Device Catalogue Number: NOT APPLICABLE
• Device Lot Number: TPUL-185015C
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/18/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 40 YR