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

Lot Number TP30L-214912A0

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Obstruction/Occlusion (2422)

Event Date 08/31/2022

Event Type  Injury  

Manufacturer Narrative

Additional mfr narrative: according to the received information, this case seems linked to a vascular skin occlusion.Vascular complications are rare serious side effects, although widely known and documented in the context of filler injections.They are related to the accidental injection of the product inside or close to a blood vessel, leading to its occlusion or compression, blocking the blood flow.If treated on time with an appropriate treatment, symptoms can be fully resolved without sequalae.If the vascular complication is not detected/diagnosed and treated timely, it can lead to a skin necrosis.The risk of such adverse reactions is mentioned in the instructions for use of teosyal products.Corrected data: no corrective actions.Teoxane is monitoring similar reactions.

Event Description

This case occured outside of the usa, in australia.According to the information received on 02-sept-2022, a nurse, being trained by a teoxane trainer, has injected a patient with teosyal rha 2 in the temples on (b)(6) 2022.It was reported that, following injection, the patient noticed an ecchymosis which became a vascular compromise in the right temple area, accompanied by blanching from right brow to hairline.It has been observed a slow vascular return (capillary return >3 sec).Immediately after, ice + pressure was applied in the area by the nurse (>10 ms).The same day, a doctor has been called for medical assistance for the management of this adverse event.And an emergency protocol was put in place with several injections of hyalase (diluted in 2% lidocaine): (b)(6) 2022: 5:25 pm, 1500 u hyalase via cannula.(b)(6) 2022: 6:10 pm, 1500 u hyalase via needle.In 6:15 pm : no visual disturbances was observed.(b)(6) 2022: 4:00 pm, 1500 u hyalase via needle.(b)(6) 2022: 4:00 pm, 1500 u hyalase via needle.(b)(6) 2022: 4:00 pm, 1500 u hyalase via needle.On (b)(6) 2022, we were informed that the patient has been reviewed by two other doctors.According to them, there was an improvement.On (b)(6) 2022, we were informed that the patient was seen by plastic surgeon.According to our latest information on (b)(6) 2022, we were informed that the patient is fully recovered.Thus the case is considered closed as is.

• 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: 15518107
• MDR Text Key: 301016306
• Report Number: 3005975625-2022-00505
• Device Sequence Number: 1
• Product Code: LMH
• Combination Product (y/n): N
• Reporter Country Code: AU
• 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: 09/30/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/30/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2023
• Device Lot Number: TP30L-214912A0
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/31/2021
• 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