BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JUVEDERM VOLUMA LIDOCAINE 1ML SKU1

    MDR report key: 3925636 · Received June 17, 2014

    Report

    Report Number
    3005113652-2014-00303
    Event Type
    Injury
    Date Received
    June 17, 2014
    Date of Event
    May 12, 2014
    Report Date
    May 21, 2014
    Manufacturer
    ALLERGAN
    Product Code
    LMH
    PMA / PMN Number
    P110033
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    FURTHER INFORMATION FROM THE REPORTER REGARDING EVENT, PRODUCT OR PATIENT DETAILS HAVE BEEN REQUESTED. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. THE EVENTS OF NECROSIS AND VASCULAR EVENT ARE PHYSIOLOGICAL COMPLICATIONS AND ANALYSIS OF THE DEVICE GENERALLY DOES NOT ASSIST ALLERGAN IN DETERMINING A PROBABLE CAUSE FOR THESE EVENTS.

    Description of Event or Problem · 1

    HEALTHCARE PROFESSIONAL REPORTED 3 DAYS AFTER INJECTION IN THE CHEEKS AND NASOLABIAL FOLDS WITH JUVEDERM VOLUMA WITH LIDOCAINE AND JUVEDERM ULTRA 3, THE PATIENT DEVELOPED "A VASCULAR INJECTED ON THE PATIENT'S LEFT SIDE OF THE FACE AND NECROSIS TO THE UPPER LIP AND BUCCAL SWAB." PATIENT WAS TREATED WITH "LOCAL SALVES." THIS IS THE SAME EVENT AND THE SAME PATIENT REPORTED UNDER MDR # 3005113652-2014-00302 (ALLERGAN COMPLAINT #(B)(4)). THIS IS THE FIRST MDR SUBMITTED FOR THE FIRST SUSPECT PRODUCT, JUVEDERM VOLUMA WITH LIDOCAINE (LOT#VB20A40061),

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    355835 JUVEDERM VOLUMA LIDOCAINE 1ML SKU1 LMH ALLERGAN NA VB20A40061

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention JUVEDERM ULTRA 3