BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JUVEDERM ULTRA XC TSK US

    MDR report key: 1983901 · Received February 4, 2011

    Report

    Report Number
    3005113652-2011-00002
    Event Type
    Injury
    Date Received
    February 4, 2011
    Date of Event
    January 8, 2011
    Report Date
    January 10, 2011
    Manufacturer
    ALLERGAN
    Product Code
    LMH
    PMA / PMN Number
    P050047
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MEDWATCH SENT TO FDA ON: (B)(4) 2011. DEVICE EVALUATION: 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 TO THE SPECIFICATIONS. THE STERILIZATION CYCLE IS REGISTERED AS CONFORMING. THE ATTRIBUTABILITY IS THEN IMPOSSIBLE TO DETERMINE.

    Description of Event or Problem · 1

    HEALTH PROFESSIONAL REPORTED FOUR DAYS AFTER INJECTING A PT IN THE GLABELLA LINE WITH JUVEDERM ULTRA XC, THE PT WENT IN AND COMPLAINED OF "SOME SWELLING." AFTER EXAMINATION, IT WAS NOTICED THE PT HAD "REDNESS AND A LINE; THIS AREA LOOKED LIKE IF IT WAS GOING TO NECROSIS." IT WAS CLARIFIED THE PT IS EXPERIENCING, "GLABELLA NECROSIS." F/U WITH THE PHYSICIAN'S OFFICE INDICATED THAT THE PT MAY HAVE AN INFECTION AND NOT NECROSIS IN THE GLABELLA. THE PT WAS SEEN SEVERAL TIMES BY THE PHYSICIAN'S OFFICE AND THE PT WAS PRESCRIBED DOXYCLINE, MOTRIN, AND NTG PASTE. THE DOXYCLINE AND MOTRIN WERE PRESCRIBED TO PREVENT WORSENING OF THE SYMPTOMS THAT MAY LEAD TO PERMANENT DAMAGE. WHEN IT WAS DETERMINED THAT THE PT MAY HAVE AN INFECTION, THE PT WAS INSTRUCTED TO STOP THE NTG PASTE AND REPLACE WITH TOPICAL NEOSPORIN. THE PT IS DOING BETTER THAN EXPECTED AND THE SYMPTOMS ARE RESOLVING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 JUVEDERM ULTRA XC TSK US LMH ALLERGAN NA H24L540762

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention