MAUDE Adverse Event Report: TEOXANE SA TEOSYAL RHA 2; HYALURONIC ACID DERMALL FILLER GEL

Model Number NOT APPLICABLE

Device Problem Positioning Problem (3009)

Patient Problem Obstruction/Occlusion (2422)

Event Date 07/08/2021

Event Type  Injury  

Manufacturer Narrative

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 sequelae.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.

Event Description

According to th received information, on (b)(6) 2021 the injector went to inject the lower lip with a teosyal rha 2 product and right away hit an artery or vein.The patient experienced a vascular occlusion which was described as white out of the lip area.The patient was immediately treated with four vials of hyaluronidase in the right lower lip and followed daily since then.According to the latest received information, the event resolved on (b)(6) 2021.

• Brand Name: TEOSYAL RHA 2
• Type of Device: HYALURONIC ACID DERMALL FILLER GEL
• Manufacturer (Section D): TEOXANE SA; rue de lyon 105; geneva, CH120 3; SZ CH1203
• Manufacturer (Section G): SAME AS CONTACT OFFICE; same as contact office
• Manufacturer Contact: fiona di folco ; rue de lyon 105; geneva, CH120-3 ; SZ CH1203
• MDR Report Key: 12251156
• MDR Text Key: 264266103
• Report Number: 3005975625-2021-00350
• 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: Nurse Practitioner
• Type of Report: Initial
• Report Date: 07/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/30/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/19/2023
• Device Model Number: NOT APPLICABLE
• Device Catalogue Number: NOT APPLICABLE
• Device Lot Number: TP30L-202514C
• Date Manufacturer Received: 07/12/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/19/2020
• 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 Age: 61 YR