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

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.

• Brand Name: TEOSYAL RHA 4/ TEOSYAL RHA 3
• 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: fiona di folco ; rue de lyon 105; geneva CH 12-03 ; SZ CH 1203
• MDR Report Key: 10326434
• MDR Text Key: 202693567
• Report Number: 3005975625-2020-00019
• Device Sequence Number: 1
• Product Code: LMH
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: P170002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 07/27/2020

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: 09/30/2020
• Device Model Number: NOT APPLICABLE
• Device Catalogue Number: NOT APPLICABLE
• Device Lot Number: TPUL-183914A/TP27L-183725C
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/27/2020
• 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): Other
• Patient Age: 42 YR