BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JUVEDERM XC

    MDR report key: 4190251 · Received October 14, 2014

    Report

    Report Number
    MW5038691
    Event Type
    Injury
    Date Received
    October 14, 2014
    Date of Event
    June 10, 2014
    Report Date
    October 14, 2014
    Manufacturer
    ALLERGAN
    Product Code
    LMH
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I RECEIVED JUVEDERM XC INJECTIONS ON MY RIGHT AND LEFT CHEEK AREA TO INCREASE THE VOLUME OF MY FACE. FOR THE FIRST 24-72 HOURS I HAD TYPICAL PAIN, SWELLING AND SORENESS THAT I WOULD EXPECT FROM AN INJECTION AND IT SUBSIDED SO I WAS FINE. HOWEVER, 5 DAYS AFTER THE INJECTION, I EXPERIENCED SEVERE LEFT MAXILLARY PRESSURE AND A HORRIBLE PAIN ON THE ROOF OF MY MOUTH. WHICH KEPT GETTING WORSE UNTIL MY PAIN WAS A 10/10. THE PAIN AND PRESSURE WAS SO SEVERE THAT I WENT TO THE ER. I RECEIVED A CT AND WAS TREATED FOR A SINUS INFECTION AND PAIN SECONDARY TO FILLER INJECTIONS. THE ER DOCTOR STATED THAT THE FILLER MAY HAVE BLOCKED A LYMPH OR NEGATIVELY AFFECTED A FACIAL NERVE. I RECEIVED ANTIBIOTICS AND TOOK PAIN MEDICATIONS FOR A MONTH. THEN I EXPERIENCED EYE PRESSURE AND PAIN. I SAW AN OPHTHALMOLOGIST WHO STATED MIGRATION CAN SOMETIMES CAUSE MAL EFFECTS AFTER HUA INJECTIONS, AND HE REFERRED ME TO AN ENT TO FOLLOW UP ON MY SYMPTOMS. DOSE OR AMOUNT: 1ML, FREQUENCY: INJECTED ONCE, ROUTE: INTRADERMAL. DATES OF USE: (B)(6) 2014. DIAGNOSIS OR REASON FOR USE: TO INCREASE FACIAL VOLUME IN THE CHEEK AREA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    649765 JUVEDERM XC NONE LMH ALLERGAN

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Hospitalization