BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REVANESSE VERSA

    MDR report key: 8242086 · Received January 11, 2019

    Report

    Report Number
    3004423487-2019-00002
    Event Type
    Malfunction
    Date Received
    January 11, 2019
    Date of Event
    May 7, 2018
    Report Date
    May 8, 2018
    Manufacturer
    PROLLENIUM MEDICAL TECHNOLOGIES INC.
    Product Code
    LMH
    PMA / PMN Number
    P160042
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE NURSE (INJECTOR) HAS STATED THAT THE PATIENT WAS INJECTED WITH REVANESSE VERSA IN THE TEAR TROUGH AREA ON FRIDAY MAY 4TH (TOTAL OF 0.8CC) THE PTIENT CALLED THE NURSE BACK ON MONDAY MAY 7TH COMPLAINING OF SEVERE SWELLING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    35438 REVANESSE VERSA DERMAL FILLER LMH PROLLENIUM MEDICAL TECHNOLOGIES INC. PN40081 17L026

    Patients

    Seq Age Sex Outcome Treatment
    1