BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JUVEDERM ULTRA PLUS XC TSK US

    MDR report key: 3932027 · Received June 20, 2014

    Report

    Report Number
    3005113652-2014-00281
    Event Type
    Injury
    Date Received
    June 20, 2014
    Date of Event
    May 16, 2014
    Report Date
    May 29, 2014
    Manufacturer
    ALLERGAN
    Product Code
    LMH
    PMA / PMN Number
    P050047
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    FURTHER INFORMATION FROM THE REPORTER REGARDING EVENT, PRODUCT, OR PT DETAILS HAS BEEN REQUESTED. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. THE EVENTS OF "ERYTHEMA", "INFLAMMATION" AND "INFECTION/IMPETIGO" ARE PHYSIOLOGICAL COMPLICATIONS AND ANALYSIS OF DEVICE GENERALLY DOES NOT ASSIST ALLERGAN IN DETERMINING A PROBABLE CAUSE FOR THESE EVENTS.

    Description of Event or Problem · 1

    HEALTHCARE PROFESSIONAL REPORTED APPROXIMATELY 4 DAYS AFTER INJECTION WITH 1 SYRINGE OF JUVEDERM ULTRA PLUS XC IN THE GLABELLA, THE PT EXPERIENCED ERYTHEMA, INFLAMMATION, AND AN IMPETIGO INFECTION AT THE INJECTION SITE. PT WENT TO AN URGENT CARE FACILITY AND WAS PRESCRIBED AN "ANTIBIOTIC"; THREE DAYS LATER THE INJECTING HEALTHCARE PROFESSIONAL ALSO PRESCRIBED TOPICAL BACTROBAN. PT SYMPTOMS RESOLVED APPROXIMATELY FIVE DAYS AFTER ONSET. THE HEALTHCARE PROFESSIONAL BELIEVES THE ETIOLOGY OF THE PT'S SYMPTOMS ARE POSSIBLY RELATED TO THE PUNCTURE OF AN UNK "CYST UNDER THE SKIN" AS THE PT HAS LATER REPORTED A PREVIOUSLY UNREPORTED HISTORY OF "CYSTS UNDER THE SKIN".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    362405 JUVEDERM ULTRA PLUS XC TSK US LMH ALLERGAN NA H30LA30310

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention