BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JUVEDERM VOLUMA WITH LIDOCAINE 1ML

    MDR report key: 4172805 · Received October 10, 2014

    Report

    Report Number
    3005113652-2014-00515
    Event Type
    Injury
    Date Received
    October 10, 2014
    Date of Event
    November 15, 2012
    Report Date
    September 16, 2014
    Manufacturer
    ALLERGAN
    Product Code
    LMH
    PMA / PMN Number
    P110033
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    FURTHER INFO FROM THE REPORTER REGARDING EVENT, PRODUCT, OR PT DETAILS HAS BEEN REQUESTED. NO ADDITIONAL INO IS AVAILABLE AT THIS TIME. THE EVENTS OF FIRM NODULE AND DELAYED INFLAMMATORY REACTION ARE PHYSIOLOGICAL COMPLICATIONS AND ANALYSIS OF THE DEVICE GENERALLY DOES NOT ASSIST ALLERGAN IN DETERMINING A PROBABLE CAUSE FOR THESE EVENTS.

    Additional Manufacturer Narrative · 1

    THE EVENTS OF NODULE/GRANULOMA IS A PHYSIOLOGICAL COMPLICATION AND ANALYSIS OF THE DEVICE GENERALLY DOES NOT ASSIST ALLERGAN IN DETERMINING A PROBABLE CAUSE FOR THIS EVENT.

    Additional Manufacturer Narrative · 1

    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 5 MONTHS AFTER INJECTION IN MALAR FAT PADS, NASOLABIAL FOLDS, MELOMENTAL FOLDS, AND LIPS WITH JUVEDERM VOLUMA WITH LIDOCAINE AND CONCOMITANT JUVEDERM VOLUMA, THE PT DEVELOPED A "1 INCH FIRM NODULE TO LEFT MMF, RIGHT MMF NODULE, AND RIGHT MALAR NODULE". THE PT WAS TREATED WITH PREDNISONE, BIAXIN VITRASE, KENALOG, AND ICE. SYMPTOMS RESOLVED WITHIN FOUR MONTHS.

    Description of Event or Problem · 1

    PATIENT WAS GIVEN A "TOPICAL 30% LIDOCAINE IN PLASTICIZED BASE" AND HIBICLENS SCRUB JUST PRIOR TO INJECTION IN ADDITION TO MIXING THE FILLER WITH "LIDOCAINE WITH EPINEPHRINE" BEFORE INJECTION.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION INFORMATION RECEIVED FROM ARTICLE "DELAYED-ONSET NODULES SECONDARY TO A SMOOTH COHESIVE 20 MG/ML HYALURONIC ACID FILLER: CAUSE AND MANAGEMENT," PUBLISHED 07/08/2015 AUTHORS NOTED THE DELAYED INFLAMMATORY REACTION WAS NOTED AS A "NODULE/GRANULOMA", BUT NO BIOPSY WAS PERFORMED TO CONFIRM THE DIAGNOSIS OF GRANULOMA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    642862 JUVEDERM VOLUMA WITH LIDOCAINE 1ML IMPLANT, DERMAL, FOR AESTHETIC USE LMH ALLERGAN NA VB20759420

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Required Intervention HIBICLENS SCRUB| JUVEDERM VOLUMA W/LIDOCAINE AND,| A LIDOCAINE W/EPINEPHRINE MIX WAS ADDED TO THE,| "TOPICAL 30% LIDOCAINE IN PLASTICIZED BASE",| CONCOMITANT JUVEDERM VOLUMA