MAUDE Adverse Event Report: TEOXANE SA RHA 3; HYALURONIC ACID DERMAL FILLER

Lot Number TP27L-23102BL1

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Foreign Body Embolism (4439)

Event Date 02/08/2024

Event Type  Injury  

Event Description

This event occured outside of the usa, in italy.The italian subsidiary notified teoxane geneva of an adverse event on 16-feb-2024.A patient was injected on (b)(6) 2024 with 0.7 ml of rha 3 in the lips (evenly distributed between the upper and lower lips).No issues occurred.  on (b)(6) 2024, a retouch was done with the same product on the lips (0.2 ml were injected between the upper and lower lips).The same day, shortly after the injection, the patient experienced a hematoma on the right side of the upper lip.  three days later, on (b)(6) 2024, the patient complained about a strong oedema accompanied by pain on the right side of the upper lip.  the next day, on (b)(6) 2024, the injector visited the patient and assessed the presence of pain, oedema, and chapped skin.  according to the injector, the symptoms described could be due to a vascular compression.This event could be caused by the pressure exerted by the injected filler in addition to the accumulation of blood, and a small pre-existing fibrotic mass (a result of previous piercing).  the patient was treated with 150 i.U.Of hyaluronidase in the right upper lip and was prescribed a dermal corticoid cream (gentalyn beta cream).On 28-feb-2024, we were informed that the patient had completely recovered and the case was closed.

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 rha 3 products.

• Brand Name: RHA 3
• Type of Device: HYALURONIC ACID DERMAL FILLER
• Manufacturer (Section D): TEOXANE SA; rue de lyon 105; geneva, 1203 ; SZ 1203
• Manufacturer Contact: morgane burgisser
• MDR Report Key: 18873040
• MDR Text Key: 337292113
• Report Number: 3005975625-2024-00117
• Device Sequence Number: 1
• Product Code: LMH
• Combination Product (y/n): N
• Reporter Country Code: IT
• 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: 03/11/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/11/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Lot Number: TP27L-23102BL1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/16/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/31/2023
• 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