BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JUVEDERM VOLUMA WITH LIDOCAINE 1 ML

    MDR report key: 4252631 · Received November 5, 2014

    Report

    Report Number
    2024601-2014-00603
    Event Type
    Injury
    Date Received
    November 5, 2014
    Date of Event
    October 9, 2014
    Report Date
    October 13, 2014
    Manufacturer
    ALLERGAN
    Product Code
    LMH
    PMA / PMN Number
    P110033
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    FURTHER INFO FROM THE REPORTER REGARDING EVENT, PRODUCT, AND PT DETAILS HAS BEEN REQUESTED. NO ADDITIONAL INFO IS AVAILABLE AT THIS TIME. THE EVENT OF EDEMA, ERYTHEMA AND PRURITUS ARE PHYSIOLOGICAL COMPLICATIONS, AND ANALYSIS OF THE DEVICE GENERALLY DOES NOT ASSIST ALLERGAN IN DETERMINING A PROBABLE CAUSE FOR THIS EVENT. DEVICE HISTORY RECORD SUMMARY: THE DOCUMENTARY RESEARCH IN THE BATCH FILE SHOWS THAT NO ELEMENT COULD EXPLAIN THESE REACTIONS: ALL THE MFG STEPS AND ALL THE PHYSICOCHEMICAL AND MICROBIOLOGICAL RESULTS (ENDOTOXINS, BIOBURDEN) ARE REGISTERED AS CONFIRMING TO THE SPECIFICATIONS. THE STERILIZATION CYCLE IS REGISTERED AS CONFORMING.

    Description of Event or Problem · 1

    HEALTHCARE PROFESSIONAL REPORTED INJECTING A PT WITH JUVEDERM VOLUMA WITH LIDOCAINE IN THE FOREHEAD. ABOUT 9 WEEKS LATER, THE PT DEVELOPED "EDEMA, ERYTHEMA AND PRURITUS AT THE INJECTION LOCATION AND AROUND." PT WENT TO THE HOSP EMERGENCY DEPARTMENT AND WAS DIAGNOSED WITH SOME SIDE EFFECT DUE TO INJECTING THE FILLER." THE PT WAS TREATED WITH HYALURONIDASE; SYMPTOMS RESOLVED 3 DAYS AFTER ONSET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    710174 JUVEDERM VOLUMA WITH LIDOCAINE 1 ML LMH ALLERGAN NA VB20A40070

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Required Intervention