BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REVANESSE VERSA+ 1.2 ML

    MDR report key: 20286458 · Received September 23, 2024

    Report

    Report Number
    3004423487-2024-00018
    Event Type
    Injury
    Date Received
    September 23, 2024
    Date of Event
    August 23, 2024
    Report Date
    September 20, 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

    AT SOME TIME APPROXIMATELY 27 MONTHS EARLIER AT PATIENT RECEIVED " REVANESSE VERSA" (UNCONFIRMED AS NO LOT # WAS PROVIDED) INTO HER LIPS BY AN RN. THERE WERE NO RECORDED ADVERSE EVENTS OR CONCERNS. TWO YEARS AND 3 MONTHS LATER THE PATIENT NOTICED A SMALL NON INFLAMED RIDGE ON HER EVERTED, INNER, UPPER LIP. THE RIDGE WAS ON THE MUCOSA IN LINE WITH THE OCCLUSION OF THE TEETH. THE LINE EVEN HAD GAPS CORRESPONDING TO THE SPACES BETWEEN THE PATIENT'S TEETH. THE INJECTOR DESCRIBED THE PATIENT AS "UNDER STRESS". THERE WAS NO MEDICAL DIRECTOR DOCUMENTED ON THE AE NOTIFICATION FORMS WHICH SUGGESTS THE PATIENT DID NOT HAVE A MEDICAL ASSESSMENT FOR HER CONCERN. MY CLINICAL OPINION IS THAT THIS DOES NOT REPRESENT AN HAVE ADVERSE EVENT. THE LINE ON THE MUCOSA OF THE UPPER LIP IS THE CLASSIC APPEARANCE SEEN WHEN SOMEONE HABITUALLY BITES ONTO THEIR LIP. THIS IS A VERY COMMON FINDING AND OCCURS MORE OFTEN WHEN INDIVIDUALS ARE NERVOUS OR STRESSED. INTERNAL REPORT NUMBER: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1343375 REVANESSE VERSA+ 1.2 ML REVANESSE VERSA+ LMH PROLLENIUM MEDICAL TECHNOLOGIES INC. 40083 10669808001038

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female