BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REVANESSE LIPS+

    MDR report key: 23507458 · Received November 9, 2025

    Report

    Report Number
    3004423487-2025-00021
    Event Type
    Injury
    Date Received
    November 9, 2025
    Date of Event
    September 27, 2025
    Report Date
    January 29, 2026
    Manufacturer
    PROLLENIUM MEDICAL TECHNOLOGIES INC.
    Product Code
    LMH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    AREA SALES MANAGER REPORTS: "A PATIENT WHO IS NEW TO LIP FILLER WAS INJECTED WITH 2.2 ML. AFTER TREATMENT THE PATIENT EXPERIENCED PAIN, SWELLING, LUMPS, BUMPS AND UNEVENNESS. AFTER BEING INSTRUCTED TO APPLY A HOT COMPRESS AND MASSAGE FOR TWO WEEKS, THE PATIENTS' LIPS ARE STILL LUMPY AND UNEVEN. SHE WANTED THE FILLER DISSOLVED." THE AREA SALES MANAGER SAYS THE FILLER HAS BEEN DISSOLVED. THE CLINIC HAS NOT PROVIDED LOT NUMBER AND OTHER INFORMATION REQUESTED TO DO THE INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    170837 REVANESSE LIPS+ IMPLANT, DERMAL, FOR AESTHETIC USE LMH PROLLENIUM MEDICAL TECHNOLOGIES INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR Female Other