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

Model Number N/A

Device Problem Migration (4003)

Patient Problem Granuloma (1876)

Event Date 03/04/2021

Event Type  Injury  

Manufacturer Narrative

According to the received information, the case seems linked to a granuloma.Granulomas are known and widely documented effects in the context of hyaluronic acid filler injections.They are caused by a delayed immune reaction of the body in response to the implant being treated as a foreign body.As it is unable to eliminate the implant, the body surrounds it with immune cells (macrophages) forming a more or less hard and inflammatory mass.Appropriate medical treatment generally allows to treat these reactions quickly and effectively.The risk of such reaction is mentioned in the instructions for use of teosyal products.

Event Description

This case occurred outside the us, in (b)(6).According to the received information, the patient was injected with teosyal rha 3 in the marionettes lines on (b)(6) 2020.The patient presented the following symptoms: in (b)(6) 2020: a cyst developed near the corner of the eye on the right side only, whereas no filler was ever injected in this area.In (b)(6) 2021: lumpiness of the marionette lines detected.In (b)(6) 2021: large palpable lumps on both sides of the face.The patient believes that the filler has migrated from the marionette lines.The lumps were reported to be firm and large in size, not painful nor inflamed.An ultrasound was performed and concluded to the diagnosis of subcutaneous granulomatous solid lesions in the lower cheek region, bilaterally near the angles of the mouth, and a cystic foci superiorly in the bilateral cheek regions.According to the latest received information, the patient wanted to wait and see if the symptoms settled.

• Brand Name: 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; SZ
• Manufacturer Contact: ornella rousseaux ; rue de lyon, 105; geneva, CH-12-03 ; SZ CH-1203
• MDR Report Key: 11648936
• MDR Text Key: 244917615
• Report Number: 3005975625-2021-00071
• Device Sequence Number: 1
• Product Code: LMH
• Combination Product (y/n): N
• PMA/PMN Number: P170002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial
• Report Date: 04/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/12/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: N/A
• Device Lot Number: TP27L-200311A0
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/14/2021
• Was Device Evaluated by Manufacturer?: No
• 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 Age: 62 YR