BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REVANESSE LIPS+ 1.2 ML

    MDR report key: 16935527 · Received May 15, 2023

    Report

    Report Number
    3004423487-2023-00013
    Event Type
    Injury
    Date Received
    May 15, 2023
    Date of Event
    April 14, 2023
    Report Date
    April 15, 2023
    Manufacturer
    PROLLENIUM MEDICAL TECHNOLOGIES INC.
    Product Code
    LMH
    UDI-DI
    10669808003032
    PMA / PMN Number
    P160042 S014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    ON (B)(6) 2023, A PATIENT WAS INJECTED WITH REVANESSE LIPS+ HA FILLER INTO THEIR LIPS. THE INJECTOR DID NOT KNOW HOW MUCH PRODUCT WAS INJECTED. AT SOME POINT IN THE PROCEDURE THE INJECTOR NOTICED BLANCHING ABOVE THE RIGHT SIDE OF THE UPPER LIP. PHOTOS SHOW BLANCHING, MOTTLING AND CIRCUMFERENTIAL COMPENSATORY VASCULAR FLUSHING. THE INJECTOR INJECTED HYLENEX TO THE INVOLVED AREA TWICE. THE VASCULAR EVENT RESOLVED WITH NO SEQUELAE. MY CLINICAL OPINION IS THAT THIS CASE REPRESENTS A CASE OF INADVERTENT INJECTION INTO A VESSEL CAUSING VASCULAR OCCLUSION WHICH WAS APPROPRIATELY MANAGED. PROLLENIUM MEDICAL TECHNOLOGIES INC. WILL CONTINUE THE INVESTIGATION AND CONTACT THE INJECTOR, PATIENT AND CLINIC TO GET MORE INFORMATION ASSOCIATED WITH THE REPORTED ADVERSE EVENT. INTERNAL REPORT NUMBER: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    628115 REVANESSE LIPS+ 1.2 ML REVANESSE LIPS+ LMH PROLLENIUM MEDICAL TECHNOLOGIES INC. 40149 10669808003032

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown