BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BELLAFILL

    MDR report key: 5403635 · Received January 28, 2016

    Report

    Report Number
    MW5059820
    Event Type
    Injury
    Date Received
    January 28, 2016
    Date of Event
    July 23, 2014
    Report Date
    January 28, 2016
    Manufacturer
    SUNEVA
    Product Code
    LMH
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MO, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    EVENT ABATED AFTER USE STOPPED OR DOSE REDUCED: NO. DIAGNOSIS OR REASON FOR USE: IT IS USED AS A COSMETIC FILLER OF THE FACE. SUNEVA, MAKERS OF NOW WHAT IS CALLED BELLAFILL, CAME TO MY OFFICE. I OWN A MEDICAL SPA, AND A NURSE INJECTED ME 2 DIFFERENT TIMES WITH THE PRODUCT EQUALING 24 SYRINGES FROM THEIR NURSE TRAINER. MY FACE IS NOT DISTORTED AND IT CAN'T BE FIXED. I HAVE PROOF BY 2 DIFFERENT PLASTIC SURGEONS. I HAVE TALKED TO MANY PLASTIC SURGEONS AND ALSO MADE SUNEVA AWARE OF THIS PROBLEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    56056 BELLAFILL BELLAFILL LMH SUNEVA

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR