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

Lot Number TP30L-202811A

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

Patient Problems Ecchymosis (1818); Pain (1994); Skin Discoloration (2074); Obstruction/Occlusion (2422)

Event Date 05/14/2021

Event Type  Injury  

Manufacturer Narrative

Vascular complications (occlusions) are well known and documented adverse reactions as part of hyaluronic acid-based dermal fillers injections.They are related to the accidental injection of the product inside or close to a blood vessel leading to an occlusion or a compression and blocking the blood flow, generally refered to as vascular complication.If the vascular complication is not detected/diagnosed and treated timely, it can lead to a skin necrosis.The risk of vascular complication and skin necrosis are mentioned in the product labelling.

Event Description

According to the received information, the patient was injected on (b)(6) 2021, in the chin area with an rha 2 product , an rha 3 product and an rha 4 product.2 linked complaints have been opened regarding the injection of rha 3 (rc/2105072) and rha 4 (rc/2105073).Upon returning from lunch the patient noticed her left chin was bruised and complained a lot of pain.The injector noticed a white halo around the bruised area that developed 2 hours after the injection and diagnosed signs of vascular occlusion.Later that night, she injected hyaluronidase and patient reported that the pain was gone.Subsequently, the bruise turned from a deep purple/black to lighter red.On (b)(6), the patient received 2 vials of hyaluronidase as treatment as well as lasering to the bruise in order to dissolve the areas in the lower face.On may 24th, the injector reported that the occlusion has completely resolved.

• Brand Name: TEOSYAL RHA 2
• Type of Device: HYALURONIC ACID DERMALL FILLER GEL
• Manufacturer (Section D): TEOXANE SA; rue de lyon; 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: 12007265
• MDR Text Key: 264270262
• Report Number: 3005975625-2021-00221
• 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: 06/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/16/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 07/06/2023
• Device Lot Number: TP30L-202811A
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/17/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/06/2020
• 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