BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JUVEDERM ULTRA

    MDR report key: 3122028 · Received May 16, 2013

    Report

    Report Number
    3005113652-2013-00059
    Event Type
    Injury
    Date Received
    May 16, 2013
    Date of Event
    April 17, 2013
    Report Date
    April 19, 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

    THE DOCUMENTARY RESEARCH IN THE BATCH FILE SHOWS THAT NO ELEMENT COULD EXPLAIN THESE REACTIONS: ALL THE MANUFACTURING STEPS AND ALL THE PHYSIOCHEMICAL AND MICROBIOLOGICAL RESULTS (ENDOTOXIN, BIOBURDEN) ARE REGISTERED AS CONFORMING TO THE SPECIFICATIONS. THE STERILIZATION CYCLE IS REGISTERED AS CONFORMING. DEVICE LABELING: PRECAUTIONS: AS WITH ALL TRANSCUTANEOUS PROCEDURES, JUVEDERM ULTRA INJECTABLE GEL IMPLANTATION CARRIES A RISK OF INFECTION. STANDARD PRECAUTIONS ASSOCIATED WITH INJECTABLE MATERIALS SHOULD BE FOLLOWED.

    Description of Event or Problem · 1

    HEALTHCARE PROFESSIONAL REPORTED AFTER INJECTION OF THE DORSUM OF THE NOSE WITH JUVEDERM ULTRA, THE PATIENT DEVELOPED AN INFECTION AT THE INJECTION SITE 1 DAY LATER. PATIENT WAS PRESCRIBED MEDROL, LEVAQUIN, CEFTIN, VALTREX, AND AN ANCEF INJECTION. SYMPTOMS HAVE RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    217086 JUVEDERM ULTRA LMH ALLERGAN NA HV24905825

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Required Intervention