BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JUVEDERM ULTRA PLUS XC/LIDO (VOLUME UNK)

    MDR report key: 3111270 · Received May 8, 2013

    Report

    Report Number
    3005113652-2013-00050
    Event Type
    Injury
    Date Received
    May 8, 2013
    Date of Event
    April 5, 2013
    Report Date
    April 9, 2013
    Manufacturer
    ALLERGAN
    Product Code
    LMH
    PMA / PMN Number
    P050047
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    NO INFORMATION

    Narratives

    Additional Manufacturer Narrative · 1

    MEDWATCH SENT TO FDA ON 05/08/2013. ATTEMPTS TO FOLLOW UP WITH THE INJECTING HEALTHCARE PROFESSIONAL HAVE BEEN UNSUCCESSFUL AND REPORTED EVENT HAS NOT BEEN CONFIRMED; LOT NUMBER AND TYPE OF PRODUCT INFORMATION ARE UNAVAILABLE AT THIS TIME. DEVICE LABELING: WARNINGS: THE PRODUCT MUST NOT BE INJECTED INTO BLOOD VESSELS. INTRODUCTION OF JUVEDERM ULTRA PLUS XC INTO THE VASCULATURE MAY OCCLUDE THE VESSELS AND COULD CAUSE INFARCTION OR EMBOLIZATION. PRECAUTIONS: AS WITH ALL TRANSCUTANEOUS PROCEDURES, DERMAL FILLER IMPLANTATION CARRIES A RISK OF INFECTION. STANDARD PRECAUTIONS ASSOCIATED WITH INJECTABLE MATERIALS SHOULD BE FOLLOWED. ADVERSE EVENTS: THE MOST COMMON INJECTION-SITE RESPONSES FOR JUVEDERM ULTRA PLUS XC WERE REDNESS, SWELLING, TENDERNESS, FIRMNESS, LUMPS/BUMPS, DISCOLORATION, AND BRUISING.

    Description of Event or Problem · 1

    PATIENT REPORTED AFTER INJECTION WITH JUVEDERM ULTRA PLUS XC IN THE FOREHEAD, THEY EXPERIENCED "MAJOR BRUISING ON THE FOREHEAD IMMEDIATELY, SWELLING ON RIGHT EYE AND FOREHEAD THE FOLLOWING DAY, PUS IN THE CORNER OF THE EYEBROW THAT LOOKS LIKE AN INFECTION, AND A BLOOD CLOT ON MY FOREHEAD." PATIENT REPORTED "DOCTOR SAID THERE IS A POSSIBILITY ONE OF THE BLOOD VESSELS WAS PUNCTURED AND IT CLOTTED." TREATMENT REPORTED AS "TWO CREAMS, FIVE ORAL MEDICATIONS, AND A SHOT IN MY FOREHEAD TO DISPERSE AND DILUTE THE JUVEDERM." TWO MEDICATIONS REPORTED AS "ANTIBIOTICS"

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    202181 JUVEDERM ULTRA PLUS XC/LIDO (VOLUME UNK) LMH ALLERGAN NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR Required Intervention