BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JUVEDERM ULTRA PLUS XC 1 ML ROW

    MDR report key: 4193425 · Received October 20, 2014

    Report

    Report Number
    3005113652-2014-00519
    Event Type
    Injury
    Date Received
    October 20, 2014
    Date of Event
    August 28, 2014
    Report Date
    September 5, 2014
    Manufacturer
    ALLERGAN
    Product Code
    LMH
    PMA / PMN Number
    P050047
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MEDWATCH SENT TO FDA ON 10/20/2014. FURTHER INFORMATION FROM THE REPORTER REGARDING EVENT, PRODUCT, OR PATIENT DETAILS HAS BEEN REQUESTED. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. THE EVENT OF "ALLERGY TO THE PRODUCT" CONSISTING OF PAIN AND REDNESS AT THE INJECTION SITE ALONG WITH DISCHARGE AND ITCHING IS A PHYSIOLOGICAL COMPLICATION AND ANALYSIS OF THE DEVICE GENERALLY DOES NOT ASSIST ALLERGAN IN DETERMINING A PROBABLE CAUSE FOR THIS EVENT.

    Description of Event or Problem · 1

    HEALTHCARE PROFESSIONAL REPORTED THE DAY AFTER INJECTION TO THE GLABELLA WITH JUVEDERM ULTRA PLUS XC PATIENT DEVELOPED AN "ALLERGY TO THE PRODUCT" CONSISTING OF "PAIN AND REDNESS" WITH "DISCRETE DISCHARGE AND ITCHING" AT THE INJECTION SITE. PATIENT WAS TREATED WITH "ANTIBIOTIC THERAPY" CONSISTING OF "CEFALEXIN" AND "TOPIC CORTISONE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    667137 JUVEDERM ULTRA PLUS XC 1 ML ROW LMH ALLERGAN NA H30LA40090

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Required Intervention SALINE| PRIOR TO INJECTION PATIENT WAS PRETREATED WITH