BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RADIESSE

    MDR report key: 1904237 · Received November 15, 2010

    Report

    Report Number
    MW5018241
    Event Type
    Injury
    Date Received
    November 15, 2010
    Date of Event
    November 10, 2010
    Report Date
    November 15, 2010
    Manufacturer
    RADIESSE
    Product Code
    LMH
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OK, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    MY SISTER WAS INJECTED WITH THE FILLER, RADIESSE, AND BECAME BLIND IN HER LEFT EYE. THIS HAPPENED IMMEDIATELY DURING THE INJECTION. DATES OF USE: (B)(6) 2010. DIAGNOSIS OR REASON FOR USE: FACIAL FILLER COSMETIC. EVENT ABATED AFTER USE STOPPED OR DOSE REDUCED: YES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RADIESSE FACIAL FILLER LMH RADIESSE

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Other| R