BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JUVEDERM ULTRA PLUS XC TSK US

    MDR report key: 3221470 · Received July 9, 2013

    Report

    Report Number
    3005113652-2013-00085
    Event Type
    Injury
    Date Received
    July 9, 2013
    Date of Event
    February 6, 2013
    Report Date
    June 11, 2013
    Manufacturer
    ALLERGAN
    Product Code
    LMH
    PMA / PMN Number
    P050047
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NO INFORMATION

    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.

    Description of Event or Problem · 1

    PATIENT REPORTED AFTER INJECTION WITH JUVEDERM ULTRA PLUS XC IN THE NASOLABIAL FOLDS AND ORAL COMMISSURES, THEY DEVELOPED SWELLING IN THE CHEEKS, "UNDER THE EYES", ORAL COMMISSURES AND MOUTH AFTER INJECTION. FOLLOW-UP WITH THE INJECTING HEALTHCARE PROFESSIONAL NOTED THAT THE PATIENT HAD ALSO BEEN INJECTED IN THE MARIONETTE LINES. THE HEALTHCARE PROFESSIONAL NOTED IMMEDIATE SWELLING AT THE INJECTION SITES FOR WHICH THE PATIENT WAS ADVISED TO TAKE ORAL BENADRYL AND APPLY TOPICAL ICE PACKS. PER THE PATIENT, THE SWELLING EVENTUALLY RESOLVED, BUT FOR MONTHS LATER REOCCURRED AND THEY WENT TO THEIR LOCAL EMERGENCY ROOM WHERE THEY WERE TREATED WITH PREDNISONE AND "A BENEDRYL DRIP".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    312687 JUVEDERM ULTRA PLUS XC TSK US LMH ALLERGAN NA H30LA20004

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Required Intervention