BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RADIESSE, VOLUMIZING FILLER

    MDR report key: 3318695 · Received August 27, 2013

    Report

    Report Number
    MW5031645
    Event Type
    Injury
    Date Received
    August 27, 2013
    Date of Event
    June 13, 2013
    Report Date
    August 26, 2013
    Manufacturer
    MERZ AESTHETICS
    Product Code
    LMH
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    WAS INJECTED UNDER THE EYES BY A MEDICAL DOCTOR (MD) WITH RADIESSE, A FILLER MANUFACTURED BY MERZ AESTHETICS. I HAVE BEEN DISFIGURED SINCE THAT DAY WITH SWOLLEN, RAISED, RED WELTS. I HAVE HAD PREDNISONE INJECTIONS, MEDROL PACK, ANTIHISTAMINES, PROTOPIC, ORACEA 40 MG AND NOTHING IS HELPING IN A SIGNIFICANT WAY. QUANTITY: LESS THAN 1CC. COSMETIC TO FILL EYE CREASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    420289 RADIESSE, VOLUMIZING FILLER RADIESSE, VOLUMIZING FILLER LMH MERZ AESTHETICS

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR ASPIRIN| CRESTOR| OMEPRAZOLE| PROTOPIC OINTMENT| ORACEA| VITAMIN D