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

Lot Number TP30L-211023A - TP30L-204211C

Device Problem Insufficient Information (3190)

Patient Problem Unspecified Vascular Problem (4441)

Event Type  Injury  

Manufacturer Narrative

Vascular complications 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

This event happened outside of the us, in (b)(6).

• Brand Name: TEOSYAL RHA 2
• Type of Device: HYALURONIC ACID DERMALL FILLER GEL
• Manufacturer (Section D): TEOXANE SA; rue de lyon 105; geneva CH120
• 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: 12142123
• MDR Text Key: 260704381
• Report Number: 3005975625-2021-00299
• Device Sequence Number: 1
• Product Code: LMH
• Combination Product (y/n): N
• PMA/PMN Number: P170002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/09/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2022
• Device Lot Number: TP30L-211023A - TP30L-204211C
• Date Manufacturer Received: 06/15/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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