BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JUVEDERM ULTRA PLUS

    MDR report key: 2030689 · Received March 18, 2011

    Report

    Report Number
    3005113652-2011-00011
    Event Type
    Injury
    Date Received
    March 18, 2011
    Date of Event
    January 27, 2011
    Report Date
    February 24, 2011
    Manufacturer
    ALLERGAN
    Product Code
    LMH
    PMA / PMN Number
    P050047
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MEDWATCH SENT TO FDA ON: (B)(4) 2011. DEVICE EVAL: THE DOCUMENTARY RESEARCH IN THE BATCH FILE SHOWS THAT NO ELEMENT COULD EXPLAIN THESE REACTIONS: ALL THE MFG STEPS AND ALL THE PHYSICOCHEMICAL AND MICROBIOLOGICAL RESULTS (ENDOTOXINS, BIOBURDEN) ARE REGISTERED AS CONFORMING TO THE SPECIFICATIONS ESPECIALLY THE EXTRUSION FORCE VALUE SHOWING AN EXPECTED CONSISTENCY OF THE PRODUCT. THE STERILIZATION CYCLE IS REGISTERED AS CONFORMING. THE ATTRIBUTABILITY IS THEN IMPOSSIBLE TO DETERMINE.

    Description of Event or Problem · 1

    HEALTH PROFESSIONAL REPORTED THAT AFTER TREATMENT WITH 2 SYRINGES OF JUVEDERM ULTRA PLUS IN THE GLABELLAR REGION, THE PT EXPERIENCED SEVERE AND PERSISTENT SWELLING, CRACKED SKIN, AND SCABBING AT THE INJECTION SITE. THE PT WAS PRESCRIBED BACTRIM AND KEFLEX TO PREVENT WORSENING OF THE SYMPTOMS THAT MAY LEAD TO PERMANENT DAMAGE. FOLLOW UP WITH THE PHYSICIAN INDICATES THAT THE PT'S SYMPTOMS ARE RESOLVING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 JUVEDERM ULTRA PLUS LMH ALLERGAN NA HV30563851

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention MULTIVITAMINS.| TOPICAL ANESTHETIC,| MEDICATIONS: BOTOX,| PT HAS A HISTORY OF TAKING THE FOLLOWING