BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REVANESSE LIPS+ 1.2 ML

    MDR report key: 22109192 · Received May 29, 2025

    Report

    Report Number
    3004423487-2025-00013
    Event Type
    Injury
    Date Received
    May 29, 2025
    Date of Event
    April 29, 2025
    Report Date
    October 6, 2025
    Manufacturer
    PROLLENIUM MEDICAL TECHNOLOGIES INC., AURORA, ONTA
    Product Code
    LMH
    Removal / Correction Number
    CCR-C-25016
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 0

    (B)(6). IS THE OFFICE MANAGER AT THE PRACTICE. THEY HAD A SAMPLE BOX OF REVANESSE LIPS. SHE WAS INJECTED AT 5:49 PM IN THE LIPS, AND OTHER AREAS OF THE LOWER FACE. SHE TEXTED ME SAYING THE DR. LOVED THE PRODUCT. AT 3:57 TODAY (B)(6) 2025), SHE CALLED TO REPORT THAT LATER THAT NIGHT (B)(6) 2025), HER BOTTOM LIP SWELLED TREMENDOUSLY TO THE POINT WHERE IT WAS VERY TIGHT AND FELT THERE WAS AN INNER TUBE IN THERE AND "CONTEMPLATED" GOING TO THE ER. SHE ALSO STATED IT WAS LUMP AND BUMPY. I WAS NOT ABLE TO GET THE LOT NUMBER.

    Description of Event or Problem · 0

    (B)(6) IS THE OFFICE MANAGER AT THE PRACTICE. THEY HAD A SAMPLE BOX OF REVANESSE LIPS. SHE WAS INJECTED AT 5:49 PM IN THE LIPS, AND OTHER AREAS OF THE LOWER FACE. SHE TEXTED ME SAYING THE DR. LOVED THE PRODUCT. AT 3:57 TODAY (B)(6) 2025), SHE CALLED TO REPORT THAT LATER THAT NIGHT (B)(6) 2025), HER BOTTOM LIP SWELLED TREMENDOUSLY TO THE POINT WHERE IT WAS VERY TIGHT AND FELT THERE WAS AN INNER TUBE IN THERE AND "CONTEMPLATED" GOING TO THE ER. SHE ALSO STATED IT WAS LUMP AND BUMPY. I WAS NOT ABLE TO GET THE LOT NUMBER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    597961 REVANESSE LIPS+ 1.2 ML REVANESSE LIPS+ 1.2 ML LMH PROLLENIUM MEDICAL TECHNOLOGIES INC., AURORA, ONTA PN40149 24H137

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Other