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

Lot Number TPUL-204221A0

Device Problem Output Problem (3005)

Patient Problem Inflammation (1932)

Event Date 10/18/2021

Event Type  Injury  

Manufacturer Narrative

Delayed inflammatory reactions that manifest as edema are well-known and documented reactions in the context of hyaluronic acid dermal filler injections.Their aetiologies are numerous.They may be related to an immune response of the body to the implant or to a bacterial infection.With medical treatment, symptoms can be quickly fully resolved, without sequelae.In addition, the risk of such reactions is mentioned in the instructions for use of teosyal products.

Event Description

According to the information received, a patient was injected for a lip treatment with teosyal rha 4 on (b)(6) 2021.This treatment was performed 40 days after the second dose of the patient covid-19 vaccine (first dose on (b)(6) 2021.And second dose on(b)(6) 2021.).Seven months after the treatment, on (b)(6) 2021, the patient complained about an inflammation and oedema of severe intensity in the lips.On (b)(6) 2021, the patient started a course of cortisone during 4 days, which completely resolved the issue.Furthermore, following receipt of the pictures on (b)(6) 2021, we considered this case as reportable due to the severity of the symptoms.

• Brand Name: TEOSYAL RHA 4
• Type of Device: HYALURONIC ACID DERMAL FILLER GEL
• Manufacturer (Section D): TEOXANE SA; rue de lyon, 105; geneva, 1203 ; SZ 1203
• Manufacturer Contact: ornella rousseaux ; rue de lyon, 105; geneva, 1203 ; SZ 1203
• MDR Report Key: 13052282
• MDR Text Key: 284882971
• Report Number: 3005975625-2021-00723
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Lot Number: TPUL-204221A0
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/26/2021
• 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