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

Model Number NOT APPLICABLE

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Granuloma (1876)

Event Date 02/15/2022

Event Type  Injury  

Event Description

According to the information received, a patient was injected in the cheekbones and chin area on (b)(6) 2021 with 1.2 ml of teosyal puresense ultradeep and 1.2 ml ofteosyal rha 4 (current complaint) in the chin area.On (b)(6) 2022, the patient complained about a visible granuloma on the right side of the mouth corner and palpable only granuloma in the left mouth corner, confirmed by ultrasound.We were also informed that the patient had received her covid-19 vaccine booster on (b)(6) 2021 and was infected by omicron on (b)(6) 2022.The medical expert of the affiliate was contacted in order to help the injector in the management of the case.On (b)(6) 2022, the injector still planned to contact the medical expert to discuss the treatment and start treating the patient.Despite reminders, we did not receive additional information at the time of this report.

• 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: 14022584
• MDR Text Key: 288684281
• Report Number: 3005975625-2022-00137
• Device Sequence Number: 1
• Product Code: LMH
• Combination Product (y/n): N
• Reporter Country Code: DE
• 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: 04/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/06/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2023
• Device Model Number: NOT APPLICABLE
• Device Catalogue Number: NOT APPLICABLE
• Device Lot Number: TPUL-212825A0
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/31/2021
• 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