BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VOLUMA

    MDR report key: 4181829 · Received October 9, 2014

    Report

    Report Number
    MW5038601
    Event Type
    Injury
    Date Received
    October 9, 2014
    Date of Event
    June 1, 2014
    Report Date
    October 7, 2014
    Manufacturer
    ALLERGAN
    Product Code
    LMH
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    VOULMA (HYALURONIC ACID) INFECTED INTO CHEEK AREA AND WITH EXPANSIONS CAUSES REFERRED PAIN TO UPPER JAWS AND GUMS. GETTING BETTER AND LIKELY SECONDARY TO INFECTION BEING GIVEN TOO DEEP. NEED WARNING! DOSE OR AMOUNT: NOT KNOWN. FREQUENCY: X1. ROUTE: SQ. DATES OF USE: GIVE INJECTION. DIAGNOSIS OR REASON FOR USE: COSMETIC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    635451 VOLUMA HYALURONIC ACID LMH ALLERGAN NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Other