BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JUVEDERM VOLUMA WITH LIDOCAINE 1ML

    MDR report key: 4861436 · Received June 19, 2015

    Report

    Report Number
    3005113652-2015-00291
    Event Type
    Injury
    Date Received
    June 19, 2015
    Date of Event
    May 17, 2015
    Report Date
    May 25, 2015
    Manufacturer
    ALLERGAN
    Product Code
    LMH
    PMA / PMN Number
    P110033
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    PHYSICIAN

    Narratives

    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. THE EVENTS OF EDEMA, HARDENED SWELLING, AND NECROSIS ARE PHYSIOLOGICAL COMPLICATIONS AND ANALYSIS OF THE DEVICE GENERALLY DOES NOT ASSIST ALLERGAN IN DETERMINING A PROBABLE CAUSE FOR THESE EVENTS. 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 AFTER INJECTION TO THE NASOLABIAL GROOVE WITH JUVEDERM VOLUMA WITH LIDOCAINE PATIENT DEVELOPED "VERY STRONG EDEMA IN RIGHT SIDE OF MENTONIAN REGION." UPON REVIEW WITH THE PHYSICIAN PATIENT PRESENTED WITH "HARDENED SWELLING IN RIGHT AND LEFT SIDE OF MENTONIAN REGION AND A VERY STRONG EDEMA IN THE INJECTION SITES." PHYSICIAN "IS AFRAID OF NECROSIS IN MENTONIAN REGION." PATIENT WAS TREATED WITH CORTICOSTEROIDS, PREDNISOLONE, AND AZITHROMYCIN WITH NO IMPROVEMENT. ANOTHER HEALTHCARE PROFESSIONAL NOTES PATIENT WAS TREATED WITH "STEROIDS, CIPRO, AND CLINDA, BUT ONLY SHOWED IMPROVEMENT WITH INCREASING DOSE OF CORTICOSTEROID FROM 20 TO 40 MG. "SYMPTOMS ARE ONGOING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    400795 JUVEDERM VOLUMA WITH LIDOCAINE 1ML IMPLANT, DERMAL, FOR AESTHETIC USE LMH ALLERGAN NA VB20A40433

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Required Intervention