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

Device Problem Malposition of Device (2616)

Patient Problem Unspecified Vascular Problem (4441)

Event Date 10/30/2020

Event Type  Injury  

Manufacturer Narrative

The reported events seems all linked to the initial vascular occlusion.Vascular complications 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, a patient has been injected in the nasolabial folds on a unknown date with a rha product (exact reference unknown) and experienced an "occlusive event in the nasolabial folds which blocked the angular artery" on an unknown date, an unknown substance was used to dissolve the occlusion.According to the latest received information the patient is "fine" but no further clarification was provided as to whether the event was resolved.The outcome of the event was unknown.The intensity of the event was not provided.(b)(4), impaired follow-up was received on 08-dec-2020 from a nurse clinician: a nurse clinician reported that a (b)(6) year-old female patient received 0.7cc rha4 in both cheeks and 0.3cc rha4 in both nasolabial folds (nlfs) on (b)(6) 2020.The injections were made with needles supplied in the rha4 kits.The injections were well tolerated with no blanching, pallor or signs of vascular compromise.On (b)(6) 2020, the subject forwarded photos to the site showing purpura and the development of vesicles in the right mid-cheek with radiation of discoloration toward the nose.The area of concern measured 1 centimeter (cm).The patient was immediately called into the office and received 0.9cc of hyaluronidase into the affected areas.In addition, the patient was instructed to use warm compresses and was started on acetylsalicylic acid (asa) 81 milligrams (mg) once daily (qd).On (b)(6) 2020, the patient returned to the office.The lesions were well demarcated and overall improved.On (b)(6) 2020, she received an additional 0.3cc of hyaluronidase and continued asa dosing.The nurse clinician believed that the event was due to vascular compression of a branch of the angular artery rather than vascular occlusion.The patient's condition until the event was resolved.

• Brand Name: 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: fiona di folco ; rue de lyon 105; geneva, CH120-3 ; SZ CH1203
• MDR Report Key: 11116228
• MDR Text Key: 231954919
• Report Number: 3005975625-2020-00047
• 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
• Type of Report: Initial
• Report Date: 01/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/05/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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