BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK JUVEDERM VOLUMA

    MDR report key: 3760928 · Received April 9, 2014

    Report

    Report Number
    2024601-2014-00209
    Event Type
    Injury
    Date Received
    April 9, 2014
    Date of Event
    March 14, 2014
    Report Date
    March 14, 2014
    Manufacturer
    ALLERGAN
    Product Code
    LMH
    PMA / PMN Number
    P110033
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    FURTHER INFO FROM THE REPORTER REGARDING EVENT, PRODUCT, OR PT DETAILS HAS BEEN REQUESTED. NO ADDITIONAL INFO IS AVAILABLE AT THIS TIME. THE EVENT HYPERSENSITIVITY RESULTING IN REDNESS, WARMTH, AND SWELLING 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 THREE MONTHS AFTER INJECTION IN MULTIPLE UNSPECIFIED INJECTION SITES WITH AN UNSPECIFIED TYPE OF JUVEDERM VOLUMA, PT DEVELOPED "LATE HYPERSENSITIVITY RESULTING IN: REDNESS, WARMTH, AND SWELLING THAT STATS ON ONE SIDE AND THEN IN THE OTHER INJECTION SITE." FURTHERMORE, THE HEALTHCARE PROFESSIONAL REPORTED A POSSIBILITY THAT THE PT DEVELOPED A FEVER WEEKS PRIOR TO THE APPARITION OF SYMPTOMS. PT WAS TREATED WITH PREDNISONE, KENCORT INJECTIONS AND HYALURONIDASES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    213283 UNK JUVEDERM VOLUMA LMH ALLERGAN NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Required Intervention