BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JUVEDERM VOLUMA XC 27G 2X 1ML

    MDR report key: 4223556 · Received October 29, 2014

    Report

    Report Number
    3005113652-2014-00551
    Event Type
    Injury
    Date Received
    October 29, 2014
    Date of Event
    September 5, 2014
    Report Date
    September 25, 2014
    Manufacturer
    ALLERGAN
    Product Code
    LMH
    PMA / PMN Number
    P110033
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVENTS OF SWELLING AND FIRMNESS ARE PHYSIOLOGICAL COMPLICATIONS AND ANALYSIS OF THE DEVICE GENERALLY DOES NOT ASSIST ALLERGAN IN DETERMINING A PROBABLE CAUSE FOR THESE EVENTS. DEVICE HISTORY RECORD SUMMARY: THE DOCUMENTARY RESEARCH IN THE BATCH FILE SHOWS THAT NO ELEMENT COULD EXPLAIN THESE REACTIONS: ALL THE MANUFACTURING STEPS AND ALL THE PHYSICOCHEMICAL AND MICROBIOLOGICAL RESULTS (ENDOTOXINS, BIOBURDEN) ARE REGISTERED AS CONFORMING TO THE SPECIFICATIONS. THE STERILIZATION CYCLE IS REGISTERED AS CONFORMING.

    Description of Event or Problem · 1

    HEALTHCARE PROFESSIONAL REPORTED THAT AFTER INJECTION IN THE "MIDFACE AND PREJOWL SULCUS" WITH JUVEDERM VOLUMA XC, THE PATIENT EXPERIENCED "SWELLING AND FIRMNESS" "ABOUT 2 WEEKS"AFTER INJECTION, BILATERALLY IN THE MIDFACE AND ON THE LEFT SIDE ONLY OF THE PREJOWL SULCUS. THE HEALTHCARE PROFESSIONAL TREATED THE PATIENT WITH ROCEPHIN AND DEXAMETHASONE INJECTIONS ONE MONTH AFTER INJECTION. A DAY LATER, THE PATIENT WAS PRESCRIBED KEFLEX AND A MEDROL DOSEPAK ORALLY. SYMPTOMS RESOLVED 6 DAYS AFTER ORAL TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    692158 JUVEDERM VOLUMA XC 27G 2X 1ML LMH ALLERGAN NA VB20A40177

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention