BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK JUVEDERM VOLUMA

    MDR report key: 3971001 · Received July 8, 2014

    Report

    Report Number
    3005113652-2014-00295
    Event Type
    Injury
    Date Received
    July 8, 2014
    Date of Event
    June 11, 2014
    Report Date
    June 11, 2014
    Manufacturer
    ALLERGAN
    Product Code
    LMH
    PMA / PMN Number
    P110033
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FURTHER INFORMATION FROM THE REPORTER REGARDING EVENT, PRODUCT, OR PATIENT DETAILS HAS BEEN REQUESTED. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. THE EVENT OF "SEVERE BURNING AND PAIN IN THE EYE" IS A PHYSIOLOGICAL COMPLICATION AND ANALYSIS OF THE DEVICE GENERALLY DOES NOT ASSIST ALLERGAN IN DETERMINING A PROBABLE CAUSE FOR THIS EVENT.

    Description of Event or Problem · 1

    HEALTHCARE PROFESSIONAL REPORTED SHORTLY AFTER INJECTION WITH UNSPECIFIED JUVEDERM VOLUMA IN THE CHEEKS, THE PATIENT DEVELOPED SEVERE BURNING AND PAIN IN THE EYE. TREATMENT PRESCRIBED INCLUDED "NUMBING EYE DROPS AND A STEROID"; TREATMENT PROVIDED INITIAL RELIEF BUT THE PAIN HAS COME BACK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    398031 UNK JUVEDERM VOLUMA LMH ALLERGAN NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Required Intervention BOTOX INJECTION TO GLABELLA