BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JUVEDERM ULTRA PLUS XC TSK US

    MDR report key: 3291422 · Received August 6, 2013

    Report

    Report Number
    3005113652-2013-00103
    Event Type
    Injury
    Date Received
    August 6, 2013
    Date of Event
    July 9, 2013
    Report Date
    July 11, 2013
    Manufacturer
    ALLERGAN
    Product Code
    LMH
    PMA / PMN Number
    P050047
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MEDWATCH SENT TO FDA ON: (B)(4)2013. DEVICE HISTORY RECORD SUMMARY: THE DOCUMENTARY RESEARCH IN THE BATCH FILE SHOWS THAT NO ELEMENT COULD EXPLAIN THESE REACTIONS: ALL THE MANUFACTURING STEPS AND ALL THE PHYSICOCHEMICAL AND MICROBIOLOGICAL RESULTS (ENDOTOXINS, BIOBURDEN) ARE REGISTERED AS CONFORMING. THE ATTRIBUTABILITY IS THEN IMPOSSIBLE TO DETERMINE. DEVICE LABELING: WARNINGS: THE PRODUCT MUST NOT BE INJECTED INTO BLOOD VESSELS, INTRODUCTIONS OF JUVEDERM ULTRA PLUS XC INTO THE VASCULATURE MAY OCCLUDE THE VESSELS AND COULD CAUSE INFARCTION OR EMBOLIZATION. 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

    HEALTHCARE PROFESSIONAL REPORTED 1 HOUR AFTER INJECTION WITH JUVEDERM ULTRA PLUS XC IN THE NASOLABIAL FOLDS, PATIENT EXPERIENCED A VASCULAR EVENT MARKED BY SKIN BLANCHING, AS WELL AS DEVELOPED BRUISING, AND SWELLING AROUND THE RIGHT NASOLABIAL FOLD INJECTION SITE. TWO DAYS AFTER THE INJECTION, PATIENT WAS TREATED WITH HYALURONIDASE. THE PATIENT WAS ALSO REPORTED TO HAVE GONE TO AN EMERGENCY ROOM; AT THIS TIME DETAILS REGARDING THE EMERGENCY ROOM VISIT HAVE NOT BEEN PROVIDED BY THE REPORTING HEALTHCARE PROFESSIONAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    369331 JUVEDERM ULTRA PLUS XC TSK US LMH ALLERGAN NA H30LA30034

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Required Intervention