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

Lot Number 221029A0

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Foreign Body Embolism (4439)

Event Date 01/13/2024

Event Type  Injury  

Manufacturer Narrative

Vascular complications are rare and serious side effects, although they are widely known and documented in the context of dermal filler injections.They are related to the accidental injection of the product inside a blood vessel, leading to its occlusion.The local deprivation of blood supply causes tissue anoxia.If enough hyaluronidase is injected on time, symptoms can be fully resolved without sequalae.If the vascular complication is not detected, diagnosed, and treated promptly, it can lead to skin necrosis.The risk of such adverse reactions is mentioned in the instructions for use of teosyal products.

Event Description

This case occured outside of the usa, in germany.A german naturopath notified teoxane of an adverse event on 13-jan-2024.A patient was injected on (b)(6) 2023 with a total of 0.8 ml of teosyal rha 4 in the corners of the mouth (0.4 ml per side) with a 22g cannula.Directly after the injection, the patient presented with a skin discoloration in the corners of the mouth and in the lip, of moderate intensity.As treatment, the injector treated the patient with 6 vials of hyaluronidase (1500 ui) the same day.The local medical expert was contacted to provide support in the case.He recommended to keep the patient for 2 additional hours in observation to test if the lips showed a normal coloration and prescribed an antibiotic (amoxiclav or ciprofloxacin).The day after, on (b)(6) 2024, the patient visited the injector again and presented with hematomas at the injection site and swelling in the lower lip.The patient received two vials of hyaluronidase and was treated with red light and enzymes.On (b)(6) 2024, the patient complained about redness under the eyes that was not there before.On (b)(6) 2024, an another doctor was contacted to manage this adverse event.He performed an ultrasound and gave the patient two additional vials of hyaluronidase.No evidence of vascular occlusion could be found.The patient was advised to continue antibiotics and also took a non-steroid anti-inflammatory drug (aspirin).Additionally, the injector continued the treatment with red light and arnica.Even if no evidence of vascular occlusion were reported, according to the pictures and the events described, a vascular compromise could not be ruled out.Thus, the case was assessed as reportable to the health authorities.On (b)(6) 2023, we were informed that the patient's situation had improved.She presented no pain, and the hematomas blew slowly away.On (b)(6) 2023, we were informed that the patient's situation was still improving and that she continued to be treated with red light and antibiotics.At the time of this report, no additional information was obtained but evolution of symptoms are being monitored.

• Brand Name: RHA 4
• Type of Device: HYALURONIC ACID DERMAL FILLER GE
• Manufacturer (Section D): TEOXANE SA; rue de lyon 105; geneva, 1203 ; SZ 1203
• Manufacturer Contact: omar mounir ; rue de lyon 105; geneva, 1203 ; SZ 1203
• MDR Report Key: 18685735
• MDR Text Key: 335187620
• Report Number: 3005975625-2024-00024
• Device Sequence Number: 1
• Product Code: LMH
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P170002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/12/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2024
• Device Lot Number: 221029A0
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/13/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/31/2022
• 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 Sex: Female