BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCULPTURA

    MDR report key: 1891151 · Received November 2, 2010

    Report

    Report Number
    MW5018004
    Event Type
    Injury
    Date Received
    November 2, 2010
    Date of Event
    June 15, 2010
    Report Date
    November 2, 2010
    Product Code
    LMH
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    KS, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    INJECTION PLACED UNDER EYE/TOP OF CHEEK. WITHIN 2 WEEKS, NODULES DEVELOPED. PROCEDURES HAVEN'T HELPED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SCULPTURA NONE LMH

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Other