BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCULPTRA

    MDR report key: 1001429 · Received February 19, 2008

    Report

    Report Number
    MW5005599
    Event Type
    Injury
    Date Received
    February 19, 2008
    Date of Event
    July 6, 2006
    Report Date
    February 19, 2008
    Product Code
    LMH
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OK, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    BUMPS UNDER EYES. SCULPTRA INJECTIONS. DATES OF USE: 2006. DIAGNOSIS OR REASON FOR USE: FILL IN HOLLOWNESS UNDER EYES. DOSE OR AMOUNT: TWO INJECTIONS. FREQUENCY: SEVERAL MOS. APART.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR