BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RADIESSE FILLER

    MDR report key: 2982740 · Received February 24, 2013

    Report

    Report Number
    MW5029169
    Event Type
    Injury
    Date Received
    February 24, 2013
    Date of Event
    January 1, 2011
    Report Date
    February 24, 2013
    Manufacturer
    MERZ AESTHETICS
    Product Code
    LMH
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I HAD RADIESSE FILLER INJECTED UNDER MY EYES. I ENDED UP WITH A BROKEN BLOOD VESSEL ON MY LEFT EYE. IT IS VERY NOTICEABLE AND PAINFUL. I COMPLAINED TO MY DOCTOR BUT HE DID NOT DO ANYTHING ABOUT IT. HE SAID THIS WOULD GO AWAY ON ITS OWN. WELL, IT HAS BEEN OVER TWO YEARS, THE BIG LUMP AND THE PAIN ARE STILL THERE. PLEASE HELP ME. THIS FILLER NEEDS TO BE TAKEN AWAY FROM THE MARKET. MY FACE IS RUINED THANKS TO RADIESSE AND THE DOCTOR WHO INJECTED THIS ON MY FACE. I WAS TOLD THE FILLER IS ONLY TEMPORARILY BUT I STILL HAVE IT UNDER MY EYES AND IT MOVES. WHAT A NIGHTMARE THIS HAS BEEN. MYSELF AND OTHER WOMEN WITH THE SAME ISSUE ARE PLANNING ON A LAWSUIT AGAINST RADIESSE. PLEASE LET ME KNOW IF YOU NEED ADDITIONAL INFORMATION FROM ME. I CAN SEND PICTURES IF NEEDED. (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    78967 RADIESSE FILLER RADIESSE INJECTABLE IMPLANT & SYRINGE LMH MERZ AESTHETICS NA

    Patients

    Seq Age Sex Outcome Treatment
    1 2 YR Other