BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REVANESSE VERSA

    MDR report key: 8242079 · Received January 11, 2019

    Report

    Report Number
    3004423487-2019-00001
    Event Type
    Malfunction
    Date Received
    January 11, 2019
    Date of Event
    April 1, 2018
    Report Date
    April 23, 2018
    Manufacturer
    PROLLENIUM MEDICAL TECHNOLOGIES INC.
    Product Code
    LMH
    PMA / PMN Number
    P160042
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PATIENT WAS INJECTED WITH REVANESSE VERSA AND EXPERIENCED PAIN, TINGLING AND SWELLING IN BOTH THE UPPER AND LOWER LIP. THE DOCTOR INDICATED HE TREATED WITH VITRASE WHICH HAS BROUGHT DOWN THE SWELLING BUT EXPRESSED CONCERN OVER THE PAIN/TINGLING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    33884 REVANESSE VERSA DERMAL FILLER LMH PROLLENIUM MEDICAL TECHNOLOGIES INC. PN40081 17K006

    Patients

    Seq Age Sex Outcome Treatment
    1