BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HA FILLERS: RHA REDENSITY, RHA 2, 3, 4; JUVEDM VOLUMA

    MDR report key: 22310175 · Received June 23, 2025

    Report

    Report Number
    MW5171779
    Event Type
    Injury
    Date Received
    June 23, 2025
    Date of Event
    May 26, 2021
    Report Date
    June 11, 2025
    Manufacturer
    TEOXANE S.A.
    Product Code
    LMH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    THIS IS THE FIRST DATE THAT DR.(B)(6) OF (B)(6) FIRST STARTED INJECTING ME WITH FACIAL FILLER. IT WAS NOT UNTIL (B)(6) OF 2025 FOLLOWING A CHANGE OF PHYSICIAN DUE TO DERMAL ADVERSE EVENT AT SAID PRACTICE THAT I WAS ALERTED TO MULTIPLE PRESENTING ADVERSE EVENTS INCLUDING TYNDALL EFFECT, EXTREME FACIAL OVERFILL CAUSING SEVERAL OTHER HEALTH ISSUES, AND PERHAPS PERMANENT TISSUE DAMAGE. I HAVE THE AMOUNTS OF FILLER USED, WHERE, AND WHEN, PER SAID PHYSICIANS¿ RECORDS, BUT SHE REFUSES TO PROVIDE THE IMAGES SHE TOOK OF THE BAR CODES VERIFYING PRODUCT AND BATCH IN A FORM THAT IS LEGIBLE. WHEN I ASKED SAID PHYSICIAN EARLY ON AS TO MIGRATED FILLER, PLEASE DISSOLVE IT, SHE SAID IT WOULD DISSOLVE ON ITS OWN AND SHE DID NOT WANT TO USE HYLANEX. INSTEAD, SHE FILLED OVER THE ISSUES PRESENTING VISUAL ASSUMETRY, LUMPS, AND TYNDALL. THIS WENT ON FOR YEARS. USED FACIAL FILLER FROM: (B)(6) 2021 TO (B)(6) 2025.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1567587 HA FILLERS: RHA REDENSITY, RHA 2, 3, 4; JUVEDM VOLUMA IMPLANT, DERMAL, FOR AESTHETIC USE LMH TEOXANE S.A.

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Female Required Intervention ADDERALL.| CLONOPIN.| MAGNESIUM CITRATE.