BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JUVEDERM (VOLUME/CONCENTRATION UNKNOWN)

    MDR report key: 3010305 · Received March 14, 2013

    Report

    Report Number
    3005113652-2013-00024
    Event Type
    Injury
    Date Received
    March 14, 2013
    Date of Event
    February 8, 2013
    Report Date
    February 13, 2013
    Manufacturer
    ALLERGAN
    Product Code
    LMH
    PMA / PMN Number
    P050047
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NO INFORMATION

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PATIENT HAS NOT APPROVED OF FOLLOW-UP WITH THE INJECTING HEALTHCARE PROFESSIONAL BY ALLERGAN MEDICAL, THEREFORE LOT NUMBER AND TYPE OF JUVEDERM NOT ATTAINABLE. DEVICE LABELING: ADVERSE EVENTS: THE MOST COMMON INJECTION-SITE RESPONSES FOR JUVEDERM ULTRA XC WERE REDNESS, SWELLING, TENDERNESS, FIRMNESS, LUMPS/BUMPS, DISCOLORATION, AND BRUISING.

    Description of Event or Problem · 1

    PATIENT REPORTED THAT AFTER INJECTION WITH JUVEDERM IN THE "MARIONETTE LINES AND A SLEEP LINE ON THE LEFT CHEEKBONE", APPROXIMATELY 2 MONTHS LATER, THE PATIENT EXPERIENCED "SWELLING OF THE LIPS AND THE LEFT CHEEKBONE, IT FEELS LIKE THE TEXTURE OF FIRM GRAPES UNDERNEATH THE SKIN ON THE CHEEK, AND ON THE TOP PORTION OF THE INSIDE CORNERS OF THE LIPS WHICH ARE RUBBING AGAINST THE TEETH AND ARE UNCOMFORTABLE". PATIENT REPORTED THAT KEFLEX AND CLARITIN WERE PRESCRIBED. IT IS UNKNOWN IF SYMPTOMS HAVE RESOLVE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    108188 JUVEDERM (VOLUME/CONCENTRATION UNKNOWN) LMH ALLERGAN NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Required Intervention SYNTHROID| BOTOX INJECTION IN THE FOREHEAD WITH NO COMPLAINT| WELLBUTRIN