BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TEOSYAL

    MDR report key: 22729059 · Received August 6, 2025

    Report

    Report Number
    MW5174104
    Event Type
    Injury
    Date Received
    August 6, 2025
    Date of Event
    May 25, 2025
    Report Date
    July 29, 2025
    Manufacturer
    TEOXANE S.A.
    Product Code
    LMH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    JO
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    TEOXANE LIP FILLER CAUSED SEVERE ANGIOEDEMA LEAVING ME WITH LIP LUMPS AND FIBROTIC TISSUE AND STILL ON MY FIRST ROUND OF HYALURONIDASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    501795 TEOSYAL IMPLANT, DERMAL, FOR AESTHETIC USE LMH TEOXANE S.A.

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Female Required Intervention