BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JUVEDERM ULTRA

    MDR report key: 2881552 · Received December 18, 2012

    Report

    Report Number
    3005113652-2012-00130
    Event Type
    Injury
    Date Received
    December 18, 2012
    Date of Event
    November 15, 2012
    Report Date
    November 23, 2012
    Manufacturer
    ALLERGAN
    Product Code
    LMH
    PMA / PMN Number
    P050047
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ALLERGAN REPRESENTATIVE REPORTED RECEIVING A REPORT FROM THE PHYSICIAN WHO NOTED THAT AFTER INJECTION WITH THREE (3) SYRINGES OF JUVEDERM ULTRA IN THE "LACRIMAL GROOVES, MALLARS, LIPS AND NASOLABIAL FOLDS", PATIENT EXPERIENCED "INTENSE EDEMA REACTIONS AND HYPEREMIA ON THE LEFT HEMIFACE, BEING MORE INTENSE ON THE DISTAL REGIONS OF THE NASOLABIAL FOLD AND LOWER MALLAR" ONE WEEK LATER. IN ADDITION, PATIENT "LOST A NEVUS THAT SHE HAD NEXT TO APPLICATION." PATIENT WAS TREATED WITH "CEFALEXIN DURING 7 DAYS AND MADE AN APPLICATION OF DIPROSAN INTRAMUSCULARLY." PATIENT IMPROVED PARTIALLY BUT RECEIVED AN ADDITIONAL TREATMENT OF "AN INJECTION OF DIPROSAN AND PRESCRIBED NONSTEROIDAL ANTI-INFLAMMATORY."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 JUVEDERM ULTRA LMH ALLERGAN NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Required Intervention