BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REVANESSE VERSA+ 1.2 ML

    MDR report key: 19552797 · Received June 17, 2024

    Report

    Report Number
    3004423487-2024-00010
    Event Type
    Injury
    Date Received
    June 17, 2024
    Date of Event
    April 30, 2024
    Report Date
    May 31, 2024
    Manufacturer
    PROLLENIUM MEDICAL TECHNOLOGIES INC.
    Product Code
    LMH
    UDI-DI
    10669808001038
    PMA / PMN Number
    P160042 S004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    ON APRIL 30, 2024, A PATIENT RECEIVED 1.2 CC OF REVANESSE VERSA+ INJECTED INTO THEIR LIPS. COMPOUNDED 23% LIDOCAINE WITH 7% TETRACINE WAS APPLIED TO THE LIPS PRIOR TO INJECTION. THE PATIENT WAS ALSO ON USINOPRIL ACE INHIBITOR FOR THE TREATMENT OF HYPERTENSION. THERE WERE NO CONCERNS OR ADVERSE EVENTS DOCUMENTED AT THE TIME OF INJECTION. PHOTOS PROVIDED SHOWED BRUISING IN BOTH LIPS HOWEVER THERE WAS MORE BRUISING IN THE UPPER LIP. FIVE (5) HOURS LATER THE PATIENT HAD MODERATE SWELLING IN THEIR UPPER LIP. THERE WAS NO PAIN, NO NODULES OR OTHER CLINICAL CONCERNS. THE PATIENT WAS GIVEN ZYRTEC AND ONE DOSE OF METHYLPREDNISOLONE AND THE SYMPTOMS COMPLETELY RESOLVED. THE HA PRODUCT WAS NOT DISSOLVED. MY CLINICAL OPINION IS THAT THIS REPRESENTS ANGIOEDEMA OF THE UPPER LIP TRIGGERED BY THE COMBINATION OF LIP TRAUMA (BRUISING) AND ACE INHIBITOR, WHICH IS WELL DOCUMENTED. TETRACAINE IS ALSO THE MOST ALLERGENIC TOPICAL ANESTHETIC AND COULD BE A CONTRIBUTING FACTOR. THE LOWER LIP DID NOT SWELL ( HA WAS INJECTED IN BOTH LIPS) AND THE REACTION SUBSIDED DESPITE THE FILLER NOT BEING DISSOLVED. IN MY OPINION THIS EXCLUDES HA FROM BEING THE CAUSE OF THE "ALLERGIC REACTION". INTERNAL REPORT NUMBER: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1009078 REVANESSE VERSA+ 1.2 ML REVANESSE VERSA+ LMH PROLLENIUM MEDICAL TECHNOLOGIES INC. 40083 23B063 10669808001038

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Female