BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK JUVEDERM VOLUMA

    MDR report key: 3893856 · Received June 12, 2014

    Report

    Report Number
    3005113652-2014-00258
    Event Type
    Injury
    Date Received
    June 12, 2014
    Date of Event
    May 20, 2014
    Report Date
    May 21, 2014
    Manufacturer
    ALLERGAN
    Product Code
    LMH
    PMA / PMN Number
    P110033
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    FURTHER INFORMATION FROM THE REPORTER REGARDING EVENT, PRODUCT, OR PATIENT DETAILS HAS BEEN REQUESTED. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. THE EVENT "EDEMA" IS A PHYSIOLOGICAL COMPLICATION AND ANALYSIS OF THE DEVICE GENERALLY DOES NOT ASSIST ALLERGAN IN DETERMINING A PROBABLE CAUSE FOR THIS EVENT.

    Description of Event or Problem · 1

    HEALTHCARE PROFESSIONAL REPORTED THAT 6 HOURS AFTER THE INJECTION WITH UNSPECIFIED JUVEDERM VOLUMA PATIENT DEVELOPED EXCESSIVE SWELLING. THE PATIENT WAS TREATED WITH LORATADINE AND INDICATES SWELLING IS SUBSIDING. THE PATIENT WAS CONCOMITANTLY INJECTED WITH JUVEDERM VOLIFT IN THE PERI ORBITAL REGION AND JUVEDERM ULTRA IN THE LIPS. THIS IS THE SAME EVENT AND THE SAME PATIENT REPORTED UNDER MDR ID #3005113652-2014-00259 (ALLERGAN COMPLAINT # (B)(4)). THIS IS THE FIRST MDR SUBMITTED FOR THE FIRST SUSPECTED PRODUCT, JEVEDERM VOLUMA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    348891 UNK JUVEDERM VOLUMA LMH ALLERGAN NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Required Intervention JUVEDERM ULTRA| JUVEDERM VOLIFT