BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JUVEDERM

    MDR report key: 1192206 · Received October 7, 2008

    Report

    Report Number
    MW5008577
    Event Type
    Injury
    Date Received
    October 7, 2008
    Date of Event
    September 5, 2008
    Report Date
    October 7, 2008
    Manufacturer
    UNKNOWN
    Product Code
    LMH
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I HAD A DOCTOR INJECT JUVEDERM IN THE FOLDS BY MY NOSE IN 2008. A FEW WEEKS LATER, I STARTED EXPERIENCING BREATHING PROBLEMS. BY APPROX SIX WEEKS LATER, I WAS IN INTENSE PAIN AND UNABLE TO BREATHE AND HAD TO BE TAKEN TO THE HOSPITAL BY AMBULANCE. AFTER NUMEROUS TESTS AT THE HOSPITAL AND IN MY DOCTOR'S OFFICE, IT WAS DETERMINED I WAS SUFFERING FROM PNEUMONIA IN BOTH LUNGS. MY DOCTOR PRESCRIBED ANTIBIOTICS AND I SLOWLY IMPROVED. I HAVE NEVER HAD RESPIRATORY PROBLEMS AND I CERTAINLY NEVER HAD PNEUMONIA BEFORE, NOR WAS I EXPOSED TO IT ANYWHERE. I AM POSITIVE THAT THE ATTACK WAS A RESULT OF THE JUVEDERM. ADDITIONALLY, I HAVE NOW DEVELOPED A TYPE OF ACNE AT THE SITE OF THE INJECTIONS. I DON'T BELIEVE THAT ACNE IS COMMON IN PEOPLE OF MY AGE. I HOPE SOMEONE WILL LOOK INTO THIS AND INVESTIGATE WHETHER OTHERS HAVE EXPERIENCED A SIMILAR REACTION. THANKING YOU IN ADVANCE. DATES OF USE: 1 DAY. DIAGNOSIS OR REASON FOR USE: COSMETIC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 JUVEDERM JUVEDERM LMH UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Hospitalization