BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REVANESSE

    MDR report key: 19886368 · Received August 1, 2024

    Report

    Report Number
    3004423487-2024-00016
    Event Type
    Injury
    Date Received
    August 1, 2024
    Date of Event
    May 20, 2024
    Report Date
    October 1, 2024
    Manufacturer
    PROLLENIUM MEDICAL TECHNOLOGIES INC.
    Product Code
    LMH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    INJECTOR SAID: INJECTED PATIENT'S CHEEKS AT THE END OF MAY, AND THE SWELLING HASN'T GONE DOWN ON ONE SIDE. INJECTOR SAID: ITS HARD AND SWOLLEN AND HAS BEEN THAT WAY SINCE SHE WAS INJECTED. IT WAS ONLY ON ONE SIDE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1216136 REVANESSE IMPLANT, DERMAL, FOR AESTHETIC USE LMH PROLLENIUM MEDICAL TECHNOLOGIES INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female