MAUDE Adverse Event Report: TEOXANE SA TEOSYAL RHA 2; DERMAL FILLER

Model Number NOT APPLICABLE

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

Patient Problem Foreign Body Embolism (4439)

Event Date 12/20/2021

Event Type  Injury  

Manufacturer Narrative

Additional mfr narrative: further attempts will be made to obtain the batch number.

Event Description

This case occurred in the united states.According to the information received on 21-dec-2021, a patient was injected on (b)(6) 2021 in the lips with a rha 2 product.During the injection, the patient experienced a vascular compression on the bottom lip and the lip became pale.As corrective treatment the patient received hyaluronidase and the event of vascular occlusion resolved, however the lip was still bruised.The patient was scheduled to have a follow-up visit with a health care professional on the next day, however no further information was received.

Event Description

This case occurred in the united states.According to the information received on (b)(6)2021, a patient was injected on (b)(6) 2021 in the lips with a rha 2 product.During the injection, the patient experienced a vascular compression on the bottom lip and the lip became pale.As corrective treatment the patient received hyaluronidase and the event of vascular occlusion resolved, however the lip was still bruised.The patient was scheduled to have a follow-up visit with a health care professional on the next day, however no further information was received.

• Brand Name: TEOSYAL RHA 2
• 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: 13276510
• MDR Text Key: 289067716
• Report Number: 3005975625-2021-00795
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/18/2022
• 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: TP30L-211517C0
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: 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 Sex: Female