BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JUVEDERM ULTRA PLUS

    MDR report key: 897301 · Received March 9, 2007

    Report

    Report Number
    3005113652-2007-00004
    Event Type
    Injury
    Date Received
    March 9, 2007
    Date of Event
    January 3, 2007
    Report Date
    February 8, 2007
    Manufacturer
    CORNEAL
    Product Code
    LMH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MEDWATCH SENT TO FDA ON 09/MAR/07. PLEASE NOTE CORNEAL INDUSTRIES IS AWAITING ASSIGNMENT OF FDA REGISTRATION. THE LOT NUMBER OF THE PRODUCT WAS PROVIDED BY THE PHYSICIAN'S OFFICE ON 09/MAR/07. A DEVICE HISTORY REVIEW IS NOW ABLE TO BE REQUESTED OF CORNEAL AND A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED WHEN THE RESULTS BECOME AVAILABLE.

    Description of Event or Problem · 1

    THE PATIENT REPORTED THAT IMMEDIATELY FOLLOWING THE JUVEDERM INJECTIONS IN THE LOWER EYE LID AREA, IT BEGAN SWELLING EXCESSIVELY. ICE PACKS WERE APPLIED TO THE AREA WITH NO SUCCESS. THREE WEEKS LATER, THE PATIENT APPLIED PREPARATION H TO THE INFLAMED ARA WITH HOPES THAT A VASOCONSTRICTING AGENT WOULD HELP WITH THE SWELLING. THE TREATING PHYSICIAN PRESCRIBED A MEDROL DOSEPAK. THE PATIENT FEELS THAT NEITHER THE PREPARATION H NOR THE MEDROL DOSE PACK HELP WITH THE SWELLING. THE PATIENT NOTES THAT THE SWELLING HAS IMPROVED GRADUALLY OVER TIME BUT THE AREA HAS NOT FULLY RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 JUVEDERM ULTRA PLUS JUVEDERM LMH CORNEAL HV30229483

    Patients

    Seq Age Sex Outcome Treatment
    1 NI YR Required Intervention PROZAC| MULTIVITAMIN