BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JUVEDERM VOLUMA XC/LIDO (VOL UNK)

    MDR report key: 3954711 · Received July 18, 2014

    Report

    Report Number
    3005113652-2014-00354
    Event Type
    Injury
    Date Received
    July 18, 2014
    Date of Event
    June 24, 2014
    Report Date
    June 24, 2014
    Manufacturer
    ALLERGAN
    Product Code
    LMH
    PMA / PMN Number
    P110033
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MEDWATCH SENT TO FDA ON: 07/18/2014. FURTHER INFORMATION FROM THE REPORTER REGARDING EVENT, PRODUCT, OR PATIENT DETAILS HAVE BEEN REQUESTED. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. THE EVENT OF MOTOR NERVE DAMAGE CAUSING THE MOUTH TO "DROOP" 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 DURING A CONFERENCE THEY ATTENDED, ONE OF THE PRESENTING PHYSICIANS MENTIONED THE FOLLOWING EVENT DURING INJECTION WITH JUVEDERM VOLUMA XC IN THE "SUBMALAR" AREA "A FACIAL NERVE MAY HAVE BEEN HIT WHICH MIGHT HAVE CAUSED MOTOR DAMAGE, CAUSING THE CORNER OF THE [PATIENT'S] MOUTH TO DROP." NO TREATMENT NOTED. THE REPORTING HEALTHCARE PROFESSIONAL COULD NOT RECALL ADDITIONAL DETAILS ABOUT THE EVENT OR WHO PRESENTED THE INFORMATION AT THE CONFERENCE. FURTHER DETAILS HAVE BEEN REQUESTED. THIS EVENT IS BEING REPORTED BECAUSE ALLERGAN'S APPROACH IS TO RESOLVE ALL DOUBT IN FAVOR OF REPORTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    422099 JUVEDERM VOLUMA XC/LIDO (VOL UNK) LMH ALLERGAN NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Disability