BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JUVEDERM VOLUMA WITH LIDOCAINE 1ML SKU1

    MDR report key: 4914815 · Received July 13, 2015

    Report

    Report Number
    3005113652-2015-00359
    Event Type
    Injury
    Date Received
    July 13, 2015
    Date of Event
    June 18, 2015
    Report Date
    June 18, 2015
    Manufacturer
    ALLERGAN
    Product Code
    LMH
    PMA / PMN Number
    P110033
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    PHYSICIAN

    Narratives

    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 PHYSIOCHEMICAL AND MICROBIOLOGICAL RESULTS (ENDOTOXINS, BIOBURDEN) ARE REGISTERED AS CONFORMING TO THE SPECIFICATIONS. THE STERILIZATION CYCLE IS REGISTERED AS CONFORMING.

    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 EVENTS OF HARDENING, SWELLING, AND DRAINAGE ARE PHYSIOLOGICAL COMPLICATIONS AND ANALYSIS OF THE DEVICE GENERALLY DOES NOT ASSIST ALLERGAN IN DETERMINING A PROBABLE CAUSE FOR THESE EVENTS. DEVICE LABELING ADDRESSES THE REPORTED EVENTS OF HARDNESS, SWELLING, AND DRAINAGE AS FOLLOWS: UNDESIRABLE EFFECTS: "THE PT MUST BE INFORMED THAT THERE ARE POTENTIAL SIDE EFFECTS ASSOCIATED WITH IMPLANTATION OF THIS PRODUCT, WHICH MAY OCCUR IMMEDIATELY OR MAY BE DELAYED. THESE INCLUDE BUT ARE NOT LIMITED TO: INFLAMMATORY REACTIONS (REDNESS, OEDEMA, ERYTHEMA, ETC.), WHICH CAN OCCUR SIMULTANEOUSLY WITH ITCHING OR PAIN ON PRESSURE, CAN APPEAR AFTER THE INJECTION. THESE REACTIONS CAN LAST FOR A WEEK. INDURATIONS OR NODULES AT THE INJECTION AREA. PTS MUST REPORT INFLAMMATORY REACTIONS WHICH PERSIST FOR MORE THAN ONE WEEK OR ANY OTHER SECONDARY EFFECT WHICH DEVELOPS, TO THEIR MEDICAL PRACTITIONER AS SOON AS POSSIBLE".

    Description of Event or Problem · 1

    HEALTHCARE PROFESSIONAL REPORTED APPROXIMATELY 6 MONTHS AFTER INJECTION TO THE CHEEKS WITH JUVEDERM VOLUMA WITH LIDOCAINE PT DEVELOPED "HARDNESS AND SWELLINGS" ON THE "LEFT SIDE OF THE FACE" ONLY. THE PHYSICIAN DRAINED THE AREA AND "SENT A SAMPLE FOR LAB ANALYSIS". PT WAS TREATED WITH HYALASE AND ORAL STEROIDS AND IS CURRENTLY TAKING ANTIBIOTICS. SYMPTOMS ARE ONGOING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    452205 JUVEDERM VOLUMA WITH LIDOCAINE 1ML SKU1 LMH ALLERGAN NA VB20A40361

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Required Intervention BORDER AND ORAL COMMISSURES