• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TEOXANE RHA2 RESILIENT HYALURONIC ACID

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

TEOXANE RHA2 RESILIENT HYALURONIC ACID Back to Search Results
Device Problem Off-Label Use (1494)
Patient Problems Obstruction/Occlusion (2422); Skin Infection (4544)
Event Date 12/20/2021
Event Type  Injury  
Event Description
Vascular occlusion on the bottom lip and the lip color became pale [vascular occlusion] lip is bruised [injection site bruising]. Rha2 was given in the lips [off label use]. United states report received from the owner of the practice on (b)(6) 2021. The owner reported that a female of unknown age received rha2 to volumize the lip, on (b)(6) 2021, dose and frequency were unknown. A volume of 1 syringe was injected to both the top and bottom lip area, using a linear thread injection technique. It was unknown if the needles from the box or if a cannula was used for the administration of rha2. Previous cosmetic procedures were unknown/ not provided. Medical history was not provided. Concomitant medications and food supplements were not provided. On (b)(6) 2021, immediately after the injections, the patient experienced a vascular occlusion on the bottom lip, which became pale. Additionally, it was reported that the lips are still bruised. The patient was prescribed with an injection of an unknown amount of hyaluronidase. The patient is scheduled to have a follow-up visit with a health care professional. The outcome of vascular occlusion was recovered/resolved. The outcome of bruising was not recovered/not resolved. It is unknown if the product was available for return. (b)(4). No additional information was available at the time of this report.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameRHA2
Type of DeviceRESILIENT HYALURONIC ACID
Manufacturer (Section D)
TEOXANE
les charmilles
rue de lyon, 105
geneva, CH-12 03
SZ CH-1203
MDR Report Key13267780
MDR Text Key283951272
Report Number3007772056-2022-00001
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 Non-Healthcare Professional
Type of Report Initial
Report Date 01/17/2022,12/20/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/17/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? No Answer Provided
Was the Report Sent to FDA? Yes
Date Report Sent to FDA01/17/2022
Distributor Facility Aware Date12/20/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 01/17/2022 Patient Sequence Number: 1
-
-