BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REVANESSE VERSA+ 1.2 ML

    MDR report key: 19839570 · Received July 26, 2024

    Report

    Report Number
    3004423487-2024-00014
    Event Type
    Injury
    Date Received
    July 26, 2024
    Date of Event
    May 30, 2024
    Report Date
    June 28, 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
    117

    Narratives

    Description of Event or Problem · 0

    ON (B)(6) 2023 A PATIENT RECEIVED 1.2 CC OF REVANAESSE VERSA+ INTO THEIR LIPS. THERE WERE NO CONCERNS OR ADVERSE EVENTS AT THE TIME OF INJECTION. AT SOME LATER UNKNOWN DATE THE PATIENT FELT THERE WAS "SWELLING AND LUMPS" IN THEIR LIPS. THE PATIENT'S PHYSICIAN PUT THE PATIENT ON PREDNISONE WHICH RESOLVED THE SYMPTOMS. ON (B)(6) 2024 THE "SWELLING AND LUMPS" RETURNED. THE PATIENT WAS SEEN BY THE INJECTOR WHO DISSOLVED THE "AREAS OF CONCERN" WITH HYLENEX AND THE PATIENTS CONCERNS RESOLVED. DUE TO THE LACK OF MEDICAL INFORMATION IN THIS CASE, IT IS DIFFICULT TO PROVIDE AN ACCURATE CLINICAL OPINION. MY VIEW IS THAT THIS REPRESENTS A CASE OF SUBOPTIMAL LIP FILLING THAT RESULTED IN LUMPY DISTRIBUTION OF PRODUCT. THIS WAS EASILY RESOLVED WITH THE INJECTION OF HYLURONIDASE. INTERNAL REPORT NUMBER: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    934240 REVANESSE VERSA+ 1.2 ML REVANESSE VERSA+ LMH PROLLENIUM MEDICAL TECHNOLOGIES INC. 40083 23A182 10669808001038

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Female