BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    JUVEDERM VOLUMA WITH LIDOCAINE 1ML

    MDR report key: 6802837 · Received August 17, 2017

    Report

    Report Number
    3005113652-2017-00851
    Event Type
    Malfunction
    Date Received
    August 17, 2017
    Date of Event
    July 11, 2017
    Report Date
    October 23, 2017
    Manufacturer
    ALLERGAN (PRINGY)
    Product Code
    LMH
    PMA / PMN Number
    P110033
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    LAB ANALYSIS OF THE DEVICE FOUND NO DEFECT.

    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. DEVICE LABELING FOR THE REPORTED EVENT OF DETACHMENT OF DEVICE COMPONENT: "METHOD OF USE-POSOLOGY: AFTER NEEDLE INSERTION AND BEFORE INJECTION, IT IS RECOMMENDED TO WITHDRAW SLIGHTLY THE PLUNGER TO ASPIRATE AND VERIFY THE NEEDLE IS NOT INTRAVASCULAR. JUVÉDERM¿ VOLUMA¿ WITH LIDOCAINE IS TO BE USED AS SUPPLIED. MODIFICATION OR USE OF THE PRODUCT OUTSIDE THE DIRECTIONS FOR USE MAY ADVERSELY IMPACT THE STERILITY, HOMOGENEITY AND PERFORMANCE OF THE PRODUCT AND IT CAN THEREFORE NO LONGER BE ASSURED."

    Description of Event or Problem · 1

    HEALTHCARE PROFESSIONAL REPORTED AN INJECTION OF JUVÉDERM¿ VOLUMA¿ WITH LIDOCAINE TO THE LATERAL ASPECT OF ZYGOMATIC ARCH. DURING INJECTION THE PLUNGER "CAME RIGHT OUT" WHILE THE PHYSICIAN WAS ASPIRATING. PACKAGED NEEDLE WAS USED. NO INJURY OCCURRED.

    Description of Event or Problem · 1

    HEALTHCARE PROFESSIONAL REPORTED AN INJECTION OF JUVÉDERM¿ VOLUMA¿ WITH LIDOCAINE TO THE LATERAL ASPECT OF ZYGOMATIC ARCH. DURING INJECTION THE PLUNGER "CAME RIGHT OUT" WHILE THE PHYSICIAN WAS ASPIRATING. PACKAGED NEEDLE WAS USED. NO INJURY OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    580267 JUVEDERM VOLUMA WITH LIDOCAINE 1ML IMPLANT, DERMAL, FOR AESTHETIC USE LMH ALLERGAN (PRINGY) VB20A70147

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Other