MAUDE Adverse Event Report: TEOXANE RHA4 RESILIENT HYALURONIC ACID

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

Patient Problem Obstruction/Occlusion (2422)

Event Date 10/30/2020

Event Type  Injury  

Event Description

United states report from a physician on 04-nov-2020. A physician reported that a female patient (unknown age) received rha on an unknown date; with unknown dose, frequency and for labial folds. An unknown volume of rha product was injected into the labial folds. The technique used for administration of rha was unknown and it was not known if a cannula was used for the administration of the rha product. Previous cosmetic procedures, medical history and concomitant medications and food supplements were not provided. An unspecified period of time following the injection of rha, the patient experienced an occlusive event in the nlf which blocked the angular artery. On an unknown date, an unknown substance was used to dissolve the occlusion. It was clarified that the patient was "fine", but no further clarification was provided as to whether the event was resolved. The outcome of the event was unknown. The intensity of the event was not provided. It was unknown if the product was available for return. Health effect: (b)(4). No additional information was available at the time of this report.

• Brand Name: RHA4
• Type of Device: RESILIENT HYALURONIC ACID
• Manufacturer (Section D): TEOXANE; les charmilles; rue de lyon, 105; geneva, CH-12 03; SZ CH-1203
• MDR Report Key: 10953527
• MDR Text Key: 219880816
• Report Number: 3007772056-2020-00003
• Device Sequence Number: 1
• Product Code: LMH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 12/04/2020,11/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/05/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Was Device Available for Evaluation?: No Answer Provided
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/04/2020
• Distributor Facility Aware Date: 09/13/2020
• Event Location: No Information
• Date Report to Manufacturer: 12/04/2020
• Was Device Evaluated by Manufacturer?: No Answer Provided
• Is the Device Single Use?: No Answer Provided
• Is This a Reprocessed and Reused Single-Use Device?: No

Type of Device Usage

Patient Treatment Data

Date Received: 12/05/2020 Patient Sequence Number: 1