BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TEOSYAL PURE SENSE REDENSITY II

    MDR report key: 14632156 · Received June 7, 2022

    Report

    Report Number
    MW5110165
    Event Type
    Injury
    Date Received
    June 7, 2022
    Date of Event
    November 1, 2020
    Report Date
    June 4, 2022
    Manufacturer
    TEOXANE S.A.
    Product Code
    LMH
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    UK
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    TWO YEARS AGO A PLASTIC SURGEON INJECTED TEOSYAL PURE SENSE REDENSITY II FILLERS TO MY CHEEKBONE AREA (ALTHOUGH I HAD ASKED FOR ONLY TEARTROUGH AREA) AND THEY CAUSED GREAT SWELLING, HUMPS/BUMPS/ DISFIGUREMENT ON MY FACE AND DISAPPEARED MY CHEEKBONES. I HAVE NUMBNESS/DISCOMFORT/FEELING OF STUFFEDNESS ON MY CHEEKBONES SINCE THEN I HAVE VISITED SEVERAL DOCTORS BUT THEY COULDN'T DISSOLVE THESE FILLERS COMPLETELY NOR COULD DETECT WHY THIS HAPPENED. I AM PRETTY SURE THERE IS STILL FILLERS THERE BECAUSE THAT AREA IS STILL WHITER/BRIGHTER AND I FEEL THE FILLER UNDERNEATH. I NEED HELP FROM YOU ABOUT WHAT THE PROBLEM IS AND HOW I CAN GET RID OF THIS COMPLICATION SINCE MY PSYCHOLOGY IS RUINED. I AM THINKING ABOUT SUING THIS COMPANY IF NONE OF THESE THINGS WORK BUT FIRST I WANT TO FOCUS ON A RESOLUTION. THANK YOU. MY PHONE: (B)(6). PS. HYALURONIC ACID FILLERS (TEOSYAL) -COMPANY TEOXANE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    323720 TEOSYAL PURE SENSE REDENSITY II IMPLANT, DERMAL, FOR AESTHETIC USE LMH TEOXANE S.A. 200324C0
    323721 TEOSYAL PURE SENSE REDENSITY II IMPLANT, DERMAL, FOR AESTHETIC USE LMH TEOXANE S.A.
    323722 TEOSYAL PURE SENSE REDENSITY II IMPLANT, DERMAL, FOR AESTHETIC USE LMH TEOXANE S.A.

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Female Required Intervention