BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REVANESSE VERSA+ (WITH LIDOCAINE)

    MDR report key: 21387774 · Received February 14, 2025

    Report

    Report Number
    3004423487-2025-00003
    Event Type
    Injury
    Date Received
    February 14, 2025
    Date of Event
    January 13, 2025
    Report Date
    February 14, 2025
    Manufacturer
    PROLLENIUM MEDICAL TECHNOLOGIES INC
    Product Code
    LMH
    PMA / PMN Number
    P160042 S004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    THE PATIENT IS A 58 YEAR OLD FEMALE. DOB: (B)(6) 1965; WITH EXTENSIVE MEDICAL HISTORY; LUNG CANCER AND BREAST CANCER, CLEARED BY DOCTOR FOR DERMAL FILLER INJECTIONS. NO ADVERSE INCIDENTS OR REACTIONS TO DERMAL FILLERS OBSERVED. NO ALLERGIES TO DERMAL FILLER TREATMENTS TOO. PATIENT DOES NOT HAVE AUTO IMMUNE CONDITIONS. THE FITZPATRICK SCALE IS 3. BASED ON THE INFORMATION/REPORT PROVIDED BY THE INJECTOR, (B)(6), RN, THE PATIENT WAS INJECTED ON (B)(6) 2024 WITH REVANESSE VERSA+ 1.2 ML TO THE LIPS AND 2 ML OF JUVEDERM VOLUMA IN THE CHEEKS. THE SECOND INJECTION WAS ON (B)(6) 2024 WITH 5ML OF VERSA+ IN THE LIPS. A TOPICAL ANESTHETIC WAS USED WHICH WAS BLT CREAM. NO OTHER MEDICATIONS ADMINISTERED BEFORE OR AFTER TREATMENT. NO OTHER INFORMATION RELATED TO THE PROCEDURE WAS PROVIDED. THE FOLLOWING WAS THE CONCERN: "PATIENT COMPLAINT ABOUT BROWN DISCOLORATION OF THE TISSUE ABOVE THE LIPS AND WHITE DISCOLORATION AREA THAT COMES AND GOES ON THE INFERIOR LIP. THE WHITE DISCOLORATION WAS NOT VISIBLE ON THE FOLLOW UP APPOINTMENT ON (B)(6) 2025. PROVIDER IS CONCERNED ABOUT THE BROWN DISCOLORATION OF THE TISSUE." RESULTS OF MEDICAL ASSESSMENT: PROLLENIUM MEDICAL TECHNOLOGIES INC. HAS CONSULTED ITS MEDICAL DIRECTOR AND HIS RESPONSE TO THE INCIDENT IS DETAILED BELOW: ON (B)(6) 2024 A PATIENT RECEIVED 1.2 CC OF VERSA + INTO HER LIPS AND 2.0 CC OF VOLUMA INTO HER CHEEKS. THERE WERE ON CONCERNS OR ADVERSE EVENTS AT THE TIME OF INJECTION. NO BEFORE PHOTO WAS PROVIDED. TOPICAL COMPOUNDED BLT WAS APPLIED PRIOR TO INJECTION. THE PATIENT HAS "AN EXTENSIVE PAST MEDICAL HISTORY INCLUDING LUNG CANCER AND BREAST CANCER". ON (B)(6) 2024 THE PATIENT RECEIVED 0.5 CC (ASSUMING 5CC WAS A TYPO) OF VERSA + INTO HER LIPS. THERE WERE NO BEFORE PHOTOS PROVIDED. THE AFTER PHOTO SHOWS A BRUISE UNDER THE VERMILLION BORDER OF THE UPPER LIP AND A PIGMENTED SPOT ABOVE THE UPPER LIP ON THE SAME SIDE AS THE BRUISE. THE MEDICAL DIRECTOR WAS NOT CONSULTED SO NO MEDICAL OPINION WAS PROVIDED. THE PIGMENTED SPOT APPEARS PREEXISTING, LIKE A FRECKLE. THERE WERE NO OTHER CONCERNS OR ADVERSE EVENTS. "MY CLINICAL OPINION IS THAT THE TINY PIGMENTED MACULE WAS PREEXISTING AND NOT DOCUMENTED WITH A PRE-PHOTO. AN ALTERNATIVE EXPLANATION IS THAT IT IS A SMALL SPOT OF PIGMENTATION RELATED TO A HEALING NEEDLE MARK. THE LATER CAUSE SHOULD RESOLVE WITHIN 8 WEEKS. I DO NOT BELIEVE THAT THE SPOT REPRESENTS AN ADVERSE EVENT, THE CLINICS MEDICAL DIRECTOR SHOULD ASSESS THE PATIENT AND OFFER A DIAGNOSIS."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    982633 REVANESSE VERSA+ (WITH LIDOCAINE) REVANESSE VERSA+ (WITH LIDOCAINE) LMH PROLLENIUM MEDICAL TECHNOLOGIES INC PN40083 23K156

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Female Required Intervention| O