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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TEOXANE RHA4 RESILIENT HYALURONIC ACID

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TEOXANE RHA4 RESILIENT HYALURONIC ACID Back to Search Results
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.
 
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Brand NameRHA4
Type of DeviceRESILIENT HYALURONIC ACID
Manufacturer (Section D)
TEOXANE
les charmilles
rue de lyon, 105
geneva, CH-12 03
SZ CH-1203
MDR Report Key10953527
MDR Text Key219880816
Report Number3007772056-2020-00003
Device Sequence Number1
Product Code LMH
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
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 Received12/05/2020
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 FDA12/04/2020
Distributor Facility Aware Date09/13/2020
Event Location No Information
Date Report to Manufacturer12/04/2020
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
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