BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REVANESSE VERSA+ (WITH LIDOCAINE) 1.2ML

    MDR report key: 23429405 · Received October 30, 2025

    Report

    Report Number
    3004423487-2025-00020
    Event Type
    Injury
    Date Received
    October 30, 2025
    Date of Event
    August 19, 2025
    Report Date
    October 30, 2025
    Manufacturer
    PROLLENIUM MEDICAL TECHNOLOGIES INC.
    Product Code
    LMH
    UDI-DI
    10669808001038
    PMA / PMN Number
    P160042 S014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE CONCERNED CLINIC HAS NOT RESPONDED WITH REPEATED REQUESTS FOR MORE INFORMATION RELATED TO THE REPORTED EVENT DESPITE MULTIPLE FOLLOW UPS. THE VOLUNTARY REPORT IS BEING FILED BASED ON LIMITED INFORMATION AVAILABLE.

    Description of Event or Problem · 0

    THE EVENT OCCURED ON AUGUST 19TH. THE EVENT WAS REPORTED TO PROLLENIUM MEDICAL TECHNOLOGIES INC. ON 01-OCT-2025. AS PER THE PATIENT: THE LOT # FOR ONLY ONE OF THE PACKAGES THAT SHE PUT IN MY LIP IS 24E144 (FOR THE CONCERNS ABOVE THE LEFT LIP AND NEXT TO CORNERS OF LEFT LIP AND UNDER THE LEFT LIP, AND ALL AROUND THE RIGHT LIP AS WELL ), HOWEVER I DON'T HAVE THE LOT # FOR THE REVANESSE VERSA VIALS/PACKAGE THAT CAUSED THE MOST EXTREME ADVERSE REACTIONS (ON THE ENTIRE RIGHT SIDE OF MY FACE INCLUDING NEXT TO MY EYES AND NOSE AND ON THE LEFT SIDE OF MY JAWLINE+UNDER IT) SUMMARY OF MY FIRST EXPERIENCE WITH REVANESSE VERSA (WHICH THE INJECTOR KEPT ON RECOMMENDING FOR MY RIGHT UNDER EYE, LEFT SIDE ONLY OF CHIN AND LIPS) INJECTED ON (B)(6) 2025 BY MED SPA IN DARIEN CT: FIRST - I ASKED FOR ONLY UNDER EYE FILLER ON THE RIGHT SIDE OF MY FACE - THE INJECTOR USED A CANNULA AND MADE SEVERAL ENTRY POINTS IN MY RIGHT CHEEK AND TOLD ME THE FILLER WOULD BE GOING TO MY UNDER EYE AND NOT MY CHEEKS HOWEVER THE FILLER STAYED THERE IN MY RIGHT CHEEK AND TURNED INTO BIG BUMPS , THE INJECTOR THEN AGGRESSIVELY MASSAGED THE BUMPS IN THE DIRECTION TOWARDS MY EYE THEN FOR ONLY THE LEFT SIDE OF MY CHIN WHICH IS ALL I ASKED FOR ON THE LEFT SIDE OF MY FACE ; THE INJECTOR AGAIN USED A CANNULA AND MADE SEVERAL ENTRY POINTS AROUND THE RAMUS OF MY JAW (SHE SAID EVEN THOUGH THE NEEDLE WAS GOING IN THERE THE FILLER WOULD NOT BE FOUND THERE , IT WOULD BE ONLY IN THE REQUESTED AREA IN THE LEFT SIDE OF MY CHIN - THIS OBVIOUSLY DID NOT HAPPEN ). SHE THEN AGGRESSIVELY MASSAGED THE FILLER FROM THE RAMUS TO MY CHIN AND BACK AND FORTH , SHE DEEPLY MASSAGED IT AND THIS WAS PAINFUL WHICH I TOLD HER. BEFORE I EVEN LEFT THIS FACILITY, I TOLD THE INJECTOR I WAS CONCERNED BECAUSE OF THE BIG HARD BUMPS THAT FORMED RIGHT AWAY IN PLACES WHERE I NEVER ASKED HER TO PUT FILLER IN. I ASKED IF SHE CAN PLEASE DISSOLVE IT AND SHE SAID NO BECAUSE IT'S NOT THE FILLER AND THAT THOSE HARD LUMPS ARE HEMATOMAS THAT WILL GO AWAY. SHE THEN TOLD ME TO TAKE AN ASPIRIN WHICH SHE GAVE ME IN A BAG , BUT LATER AT HOME WHEN I CHECKED TO SEE IF IT WAS SAFE TO TAKE THAT WITH THE SYMPTOMS I WAS HAVING ALL THE GUIDANCE I FOUND SUGGESTED THAT ASPIRIN WOULD ONLY MAKE IT WORSE. I AM STILL VERY UNHAPPY WITH THE LACK OF PROFESSIONALISM AND CARE FROM THIS MEDICAL FACILITY. *PLEASE NOTE : I HAVE HAD EXPERIENCE WITH ONLY RESTYLANE FILLER IN MY FACE IN THE PAST (ALMOST A YEAR NOW) WITH A DIFFERENT INJECTOR AND I NEVER HAD ANY REACTION LIKE THIS BEFORE, I ALSO HAVE BEFORE AND IMMEDIATELY AFTER PICTURES OF HOW I'M SUPPOSED TO LOOK AFTER GETTING FILLER IN MY FACE AND THIS EXPERIENCE ON (B)(6) WAS DEFINITELY VERY TRAUMATIC : IMMEDIATELY AFTER LEAVING THE MED SPA IN DARIEN CT THOSE BUMPS BECAME VERY WARM TO THE TOUCH AND THEY BECAME HARDER AND PAINFUL. IT STARTED TO PULL MY FACE DOWNWARDS AND IT AFFECTED MY DENTAL BITE ( I FELT THE PRESSURE OF IT MOVING OR RESTRICTING MY JAW) , AND I COULDN'T MOVE MY MOUTH TO TALK. ALL THESE SYMPTOMS PERSISTED UNTIL I WENT SOMEWHERE ELSE WHERE I COULD TRUST THEY WOULDN'T KEEP CLAIMING IT'S A "HEMATOMA" AND THEY DISSOLVED SOME OF THE FILLER FOR ME WHICH BROUGHT SOME RELIEF. ALSO, PUS STARTED COMING OUT THE PLACES WHERE SHE MADE HER ENTRY POINTS. SINCE (B)(6) I HAVE BEEN SUFFERING BECAUSE IT WAS CLEAR THE FILLER WAS NEVER CORRECTLY PLACED AND ON TOP OF THAT THERE IS THE CONCERN THAT I'VE EXPRESSED TO THE INJECTOR ABOUT THE CAUTION THAT NEEDS TO BE APPLIED DUE TO THE FACT THAT I HAVE TITANIUM PLATES IN MY FACE(WHICH MY OLD INJECTOR WAS SUPER CAUTIOUS OF SO I UNDERSTAND THE IMPORTANCE OF THAT TO SOME DEGREE ). INTERNAL REPORT NUMBER: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1356849 REVANESSE VERSA+ (WITH LIDOCAINE) 1.2ML REVANESSE VERSA+ LMH PROLLENIUM MEDICAL TECHNOLOGIES INC. PN40083 24E144 10669808001038

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Female