BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JUVEDERM ULTRA PLUS/30HV (VOLUME UNKNOWN)

    MDR report key: 4092362 · Received September 4, 2014

    Report

    Report Number
    3005113652-2014-00419
    Event Type
    Injury
    Date Received
    September 4, 2014
    Date of Event
    August 7, 2014
    Report Date
    August 7, 2014
    Manufacturer
    ALLERGAN
    Product Code
    LMH
    PMA / PMN Number
    P050047
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    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 EVENT "SWELLING AND INDURATION" IS A PHYSIOLOGICAL COMPLICATION AND ANALYSIS OF THE DEVICE GENERALLY DOES NOT ALLERGAN IN DETERMINING A PROBABLE CAUSE FOR THIS EVENT.

    Description of Event or Problem · 1

    HEALTHCARE PROFESSIONAL REPORTED THAT AFTER INJECTION IN AN UNSPECIFIED INJECTION SITE OR SITES WITH JUVEDERM ULTRA PLUS, THE PATIENT DEVELOPED "SWELLING AND INDURATION IN CHEEKS, AND AROUND THE MOUTH" "9 DAYS" AFTER INJECTION. PATIENT WAS CONCOMITANTLY INJECTED WITH JUVEDERM VOLUMA XC. AMOXICILLIN AND A "DOSEPAK" WERE PROVIDED AS TREATMENT AND THE SYMPTOMS VEGAN TO RESPOND, BUT WHEN THE "STEROID" DOSE TAPERED, PATIENT REACTIONS BEGAN TO EXACERBATE AGAIN. THIS IS THE SAME EVENT AND THE SAME PATIENT REPORTED UNDER MDR ID # 3005113652-2014-00427 ((B)(4)). THIS IS THE FIRST MDR SUBMITTED FOR THE FIRST SUSPECT PRODUCT, JUVEDERM ULTRA PLUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    541491 JUVEDERM ULTRA PLUS/30HV (VOLUME UNKNOWN) LMH ALLERGAN NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention JUVEDERM VOLUMA XC