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

Model Number NOT APPLICABLE

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Granuloma (1876)

Event Date 12/15/2020

Event Type  Injury  

Manufacturer Narrative

Granulomas are known and widely documented effects in the context of hyaluronic acid filler injections.They are caused by a delayed immune reaction of the body in response to the implant being treated as a foreign body.As it is unable to eliminate the implant, the body surrounds it with immune cells macrophages forming a more or less hard and inflammatory mass.With medical treatment, symptoms can be quickly fully resolved, without sequelae.Literature data.De boulle k, heydenrych i.Patient factors influencing dermal filler complications: prevention, assessment, and treatment.Clin cosmetic 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

The event occurred outside of the us, in (b)(6).According to the information received so far, the patient received injections of.Teosyal rha 4 2 ml; lot# tpul194311b; complaint ref.Rc/2101037, and teosyal puresense ultra deep 1 ml; lot# tsul 194213b; complaint ref.Rc 2102026 in the chin on (b)(6).2020.Approximately 3 to 3.5 months later (b)(6) 2020, the patient presented a late inflammatory reaction, which was diagnosed as granuloma via ultrasound.The patient was treated with hyaluronidase on (b)(6).2020, then again on (b)(6).2021.She also received corticosteroids urbason, descending pattern for 2 weeks' duration.A medical expert was contacted for support on this case.He indicated that the patient has been taking deflazacort 30 mg for 7 days.As of (b)(6).2021, the patient worsened because, according to the medical expert, she has decided to lower the dose of corticosteroids.Additionally, the patient appeared to be an apprehensive person.As of (b)(6).2021, the analysis of the patient, which included hematology, thyroid profile and crp, has come out normal.The ultrasound is pending a full report.We were informed on (b)(6).2021 that the granuloma diagnosis was confirmed for areas that were treated with teosyal rha 4 and teosyal puresense ultra deep the exact products involved were initially unclear.The expert helped collect data about the treatments provided to the patient and the reason behind the temporary worsening.Also, a follow-up of the patient was performed via the spanish affiliate to monitor the evolution of the symptoms.On (b)(6).2021, it was confirmed that the adverse event was resolved.

• 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
• Manufacturer Contact: ornella rousseaux ; rue de lyon, 105; geneva, CH-12-03 ; SZ CH-1203
• MDR Report Key: 11422974
• MDR Text Key: 246472332
• Report Number: 3005975625-2021-00019
• 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: foreign,health professional
• Type of Report: Initial
• Report Date: 03/05/2021

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: 10/31/2021
• Device Model Number: NOT APPLICABLE
• Device Catalogue Number: NOT APPLICABLE
• Device Lot Number: TPUL-194311B
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/04/2021
• Initial Date FDA Received: 03/05/2021
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/31/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 49 YR