BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JUVEDERM ULTRA PLUS/30HV (VOLUME UNKNOWN)

    MDR report key: 3445398 · Received October 29, 2013

    Report

    Report Number
    3005113652-2013-00165
    Event Type
    Injury
    Date Received
    October 29, 2013
    Date of Event
    September 15, 2013
    Report Date
    October 1, 2013
    Manufacturer
    ALLERGAN
    Product Code
    LMH
    PMA / PMN Number
    P050047
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE LABELING: INTENDED USE/INDICATIONS JUVEDERM ULTRA PLUS INJECTABLE GEL IS INDICATED FOR INJECTION INTO THE MID TO DEEP DERMIS FOR CORRECTION OF MODERATE TO SEVERE FACIAL WRINKLES AND FOLDS (SUCH AS NASOLABIAL FOLDS). WARNINGS: INJECTION PROCEDURE REACTION TO JUVEDERM ULTRA PLUS INJECTABLE GEL HAS BEEN OBSERVED AS CONSISTING MAINLY OF SHORT-TERM INFLAMMATORY SYMPTOMS STARTING EARLY AFTER TREATMENT AND WITH LESS THAN 7 DAYS' DURATION. ADVERSE EVENTS: INJECTION SITE RESPONSES INCLUDE REDNESS, PAIN/TENDERNESS, FIRMNESS, SWELLING, LUMPS/BUMPS, BRUISING, ITCHING, AND DISCOLORATION.

    Description of Event or Problem · 1

    IN THE ARTICLE "OFFICE-BASED INJECTION LARYNGOPLASTY WITH HYALURONIC ACID GEL". OTOLARYNGOLOGY-HEAD AND NECK SURGERY (SEP-2013) 147(5), THE AUTHORS DISCUSSED A STUDY THEY PERFORMED INVOLVING OFFICE-BASED INJECTION LARYNGOPLASTY WITH "JUVEDERM ULTRA PLUS GEL IN PTS WITH GLOTTIC INSUFFICIENCY (GI)". DURING THE STUDY "ONE PT REQUIRED INTRAVENOUS STEROID THERAPY FOR TEMPORARY GLOTTIS INFLAMMATION THAT RESOLVED WITHOUT PERMANENT SEQUELAE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    553853 JUVEDERM ULTRA PLUS/30HV (VOLUME UNKNOWN) LMH ALLERGAN NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Required Intervention