MAUDE Adverse Event Report: TEOXANE SA RHA 2 / RHA 4 / RHA 3; HYALURONIC ACID DERMAL FILLER GEL

Lot Number 200911A0/200916A0/200711A0

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

Patient Problems Ecchymosis (1818); Pain (1994); Unspecified Vascular Problem (4441); Skin Infection (4544); Injection Site Reaction (4562)

Event Date 09/11/2020

Event Type  Injury  

Manufacturer Narrative

The reported events seems all linked to the initial vascular compression.Vascular complications (occlusions) are well known and documented adverse reactions as part of hyaluronic acid-based dermal fillers injections.They are related to the accidental injection of the product inside or close to a blood vessel leading to an occlusion or a compression and blocking the blood flow, generally refered to as vascular complication.If the vascular complication is not detected/diagnosed and treated timely, it can lead to a skin necrosis.The risk of vascular complication and skin necrosis are mentioned in the product labelling.Literature data: de boulle k, heydenrych i.Patient factors influencing dermal filler complications: prevention, assessment, and treatment.Clin cosmet investig 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.Delorenzi, c.(2014)."complications of injectable fillers, part 2: vascular complications." aesthetic surgery journal/the american society for aesthetic plastic surgery 34(4): 584-600.

Event Description

According to the received information, one day after the injections of rha 2, rha 3 and rha 4 in the naso-labial folds, patient reported pain and mild bruising in the left nlf.Two days later, the patient complained about the formation of pustules in the left nasal alar region with mild pain.The patient's father, a physician, evaluated the patient and after communicating with the injecting physician's office, he injected the patient with 150 units of hylenex (hyaluronidase) in the left nasolabial fold.On (b)(6) 2020, the patient visited a local dermatologist who injected her with 300 units of vitrase (hyaluronidase product).It was additionally reported the patient was started on amoxicillin twice a day, acetylsalicylic acid (asa) 325mg and local application of nitro paste.On (b)(6) 2020, the patient was evaluated by another dermatologist who agreed with the treatment plan and the patient reported her signs and symptoms were improving.On (b)(6) 2020, it was reported the patient's pain had improved and the affected area showed progressive improvement.On (b)(6) 2020, it was reported the patient continues to improve with no apparent long standing issues.The patient had a little peeling skin in the left nasal alar region but overall she was healing well.On (b)(6) 2020, it was reported the patient was doing well.The patient was still experiencing a small amount of redness and dry skin in the area, but was healing well.The physician's assistant stated that she believed the event represented "vascular compression" not "vascular occlusion" due to the length of time it took the patient to present with symptoms.It was additionally reported that all signs and symptoms of vascular compression have resolved.The intensity of the events of pustules at the left nasal alar region and vascular compression was not reported and the intensity of the events of pain and bruising in the left nasolabial fold was reported as mild.The outcome of the events was resolved.

• Brand Name: RHA 2 / RHA 4 / 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: nicolas caill ; rue de lyon, 105; geneva, CH-12-03 ; SZ CH-1203
• MDR Report Key: 10660993
• MDR Text Key: 216581222
• Report Number: 3005975625-2020-00024
• Device Sequence Number: 1
• Product Code: LMH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P170002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/12/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/10/2023
• Device Lot Number: 200911A0/200916A0/200711A0
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/15/2020
• 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: 30 YR