BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JUVEDERM ULTRA PLUS XC TSK US

    MDR report key: 2202042 · Received August 5, 2011

    Report

    Report Number
    3005113652-2011-00058
    Event Type
    Injury
    Date Received
    August 5, 2011
    Date of Event
    June 28, 2011
    Report Date
    July 11, 2011
    Manufacturer
    ALLERGAN
    Product Code
    LMH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    NO INFORMATION

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATION SUMMARY: BATCH NUMBER H30L601772 WAS RELEASED BY QC ACCORDING TO DEFINED SPECIFICATIONS. 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 AND THE STERILITY TEST ARE REGISTERED AS CONFORMING. THE ATTRIBUTABILITY IS THEN IMPOSSIBLE TO DETERMINE.

    Description of Event or Problem · 1

    PATIENT REPORTED AN ADVERSE EVENT AFTER AN INJECTION WITH JUVEDERM. THE PHYSICIAN CONFIRMED THAT THE PATIENT WAS INJECTED WITH JUVEDERM ULTRA XC IN THE NASOLABIAL FOLDS AND THE MARIONETTE LINES. TWO WEEKS LATER, THE PATIENT HAD AN UNRELATED SURGERY IN THE LEFT EAR TO REMOVE A BASAL CARCINOMA LESION. THE PATIENT DID FINE UNTIL THE PATIENT DEVELOPED INFLAMED AREAS IN BOTH SIDES OF THE FACE AND ALSO IN THE CHIN AREA. THE RIGHT NASOLABIAL FOLD WAS ALSO INFECTED. THE PHYSICIAN TREATED THE AREAS WITH INTRALESIONAL STEROIDS AND KEFLEX 500MG TWICE A DAY FOR 7 DAYS. ALL SYMPTOMS HAVE RESOLVED, EXCEPT ON THE RIGHT SIDE OF THE FACE. THE PHYSICIAN PLANS TO TREAT THE PATIENT ONCE MORE WITH INTRALESIONAL MEDICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 JUVEDERM ULTRA PLUS XC TSK US LMH ALLERGAN NA H30L601772

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Required Intervention