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

Model Number NOT APPLICABLE

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Skin Infection (4544)

Event Type  Injury  

Manufacturer Narrative

Additional mfr narrative: skin infections are well known and described adverse reactions following dermal filler injections.They can happen after an injection with an improper technique, inducing a lack of asepsis of the injection environment, which in some case may result in sepsis.External factors, such as the use of makeup immediately after the injection, can also increase the risk of skin infection.Adequate treatment with antibiotics leads to a complete resolution of the symptoms without sequelae.Additionally, the risk of such adverse events is mentioned in the instructions for use of teosyal products.

Event Description

According to the received information, the patient was injected with an unknown amount of rha 3 in the nasolabial folds and three syringes of rha 4 in the cheeks on (b)(6) 2021.At the beginning of (b)(6), the patient experienced unilateral under eye swelling which progressively became worse, the full medial and lateral cheek of the right side became swollen, red, and tender, showing signs of infection.No symptoms occured in the nasolabial folds so only rha 4 product was considered.In the last week of (b)(6) 2022, the patient underwent a ct scan which showed chronic sinus infection and sinus polyps.A biopsy was scheduled on (b)(6) 2022 but it is unknown at the time of this report if the procedure was done.In an unknown date in (b)(6) 2022, the patient was prescribed antibiotics.The events were ongoing at the time of this report.No additional information could be retrieved.

• Brand Name: TEOSYAL RHA 4
• Type of Device: DERMAL FILLER
• Manufacturer (Section D): TEOXANE SA; rue de lyon; 105; geneva 1203 ; CH 1203
• Manufacturer (Section G): TEOXANE SA; rue de lyon; 105; geneva 1203 ; CH 1203
• Manufacturer Contact: nicolas caill ; rue de lyon; 105; geneva 1203 ; CH 1203 ; 022344-963
• MDR Report Key: 13860892
• MDR Text Key: 289103436
• Report Number: 3005975625-2022-00098
• 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: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/23/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: NOT APPLICABLE
• Device Catalogue Number: NOT APPLICABLE
• Device Lot Number: TPUL
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• 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