BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXPRESSIONS

    MDR report key: 4189873 · Received October 14, 2014

    Report

    Report Number
    MW5038673
    Event Type
    Injury
    Date Received
    October 14, 2014
    Date of Event
    November 1, 2013
    Report Date
    October 14, 2014
    Manufacturer
    ENHANCEMENT MEDICAL LLC
    Product Code
    LYA
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    WAS INJECTED WITH EXPRESSIONS AS A DERMAL FILLER UNDER MY EYES AND MY CHEEKBONES. I HAVE EXPERIENCED MONTHLY SWELLING AND HARD NODULES UNDER MY EYES. ALSO WITH PAIN RADIATING DOWN TO MY UPPER TEETH. ALSO, FOR THE PAST YEAR EXPERIENCED ALLERGY TYPE SYMPTOMS THAT INCLUDE NASAL CONGESTION AND NASAL BURNING. DATE THE PERSON FIRST STARTED TAKING OR USING THE PRODUCT: (B)(6) 2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    648745 EXPRESSIONS EXPRESSIONS LYA ENHANCEMENT MEDICAL LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR