BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REVANESSE VERSA+ 1.2 ML

    MDR report key: 17007659 · Received May 25, 2023

    Report

    Report Number
    3004423487-2023-00017
    Event Type
    Injury
    Date Received
    May 25, 2023
    Date of Event
    February 7, 2023
    Report Date
    May 25, 2023
    Manufacturer
    PROLLENIUM MEDICAL TECHNOLOGIES INC., AURORA, ON,
    Product Code
    LMH
    UDI-DI
    10669808001038
    PMA / PMN Number
    P160042 S004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    117

    Narratives

    Description of Event or Problem · 0

    ON (B)(6) 2023, A PATIENT WAS INJECTED WITH 0.8 ML OF REVANESSE VERSA+ HA FILLER INTO THEIR LIPS. A TOPICAL ANESTHETIC WAS USED, OINTMENT LIDOCAINE 23%, TETRACAINE 7%, LIPS. PATIENT HAD A VIRAL INFECTION AND WAS IN BED FOR 2-3 DAYS. SHE NOTICED HER LIPS GOT SWOLLEN AND FORMED 2 LITTLE LUMPS. NO TREATMENT WAS GIVEN. SHE JUST MONITORED IT. IN A COUPLE OF DAYS WHEN SHE WAS FEELING BETTER, THE LIPS WERE NO LONGER SWOLLEN AND THE NODULES WENT AWAY. PROLLENIUM MEDICAL TECHNOLOGIES INC. WILL CONTINUE THE INVESTIGATION. INTERNAL REPORT NUMBER: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1640117 REVANESSE VERSA+ 1.2 ML REVANESSE VERSA+ LMH PROLLENIUM MEDICAL TECHNOLOGIES INC., AURORA, ON, 40083 10669808001038

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR Female