BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JUVEDERM ULTRA PLUS XC TSK US

    MDR report key: 3231387 · Received July 15, 2013

    Report

    Report Number
    3005113652-2013-00089
    Event Type
    Injury
    Date Received
    July 15, 2013
    Date of Event
    June 14, 2013
    Report Date
    June 17, 2013
    Manufacturer
    ALLERGAN
    Product Code
    LMH
    PMA / PMN Number
    P050047
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MEDWATCH SENT TO FDA ON (B)(4) 2013. DEVICE LABELING: ADVERSE EVENTS: THE MOST COMMON INJECTION-SITE RESPONSES FOR JUVEDERM ULTRA PLUS XC WERE REDNESS, SWELLING, TENDERNESS, FIRMNESS, LUMPS/BUMPS, DISCOLORATION, AND BRUISING. POSTMARKET SURVEILLANCE. ADVERSE EVENTS WITH A FREQUENCY OF 5 OR MORE EVENTS ARE LISTED IN ORDER OF PREVALENCE: INFLAMMATION AT THE INJECTION SITE, ALLERGIC REACTION, BLISTER, INFECTION AT THE INJECTION SITE, SKIN RASH, BLEEDING AT THE INJECTION-SITE, NECROSIS AT THE INJECTION SITE, ABSCESS AT THE INJECTION SITE, AND HEADACHE.

    Description of Event or Problem · 1

    HEALTHCARE PROFESSIONAL NOTED APPROXIMATELY TWO WEEKS AFTER INJECTION IN THE NASOLABIAL FOLDS, MARIONETTE LINES, AND "PRE-JOWL SULCUS" WITH THREE SYRINGES OF JUVEDERM ULTRA PLUS XC, THE PATIENT DEVELOPED "PUFFY CHEEKS AND SWELLING ON THE CHIN, NODULAR INDURATION AT NASOLABIAL FOLDS, REDNESS AND ITCHING AT THE SITE OF INJECTIONS... A DELAYED ALLERGIC REACTION." PATIENT WAS TREATED WITH HYALURONIDASE AND "ORAL STEROIDS", NODULES RESOLVED, BUT THE SKIN AT THE INJECTION SITES APPEARED DRY WITH SLIGHT ERYTHEMA. PATIENT WAS ADVISED TO APPLY MASSAGE AND WARM COMPRESSES TO THE INJECTION SITES; SYMPTOMS HAVE "SIGNIFICANTLY IMPROVED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    327790 JUVEDERM ULTRA PLUS XC TSK US LMH ALLERGAN NA H30LA30032

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention NEXIUM| TOPICAL LIDOCAINE APPLIED PRIOR TO JUVEDERM,| FLUOXETINE| INJECTION| NASAL SPRAYS