BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JUVEDERM VOLUMA WITH LIDOCAINE 1ML SKU1

    MDR report key: 4121275 · Received September 22, 2014

    Report

    Report Number
    3005113652-2014-00475
    Event Type
    Injury
    Date Received
    September 22, 2014
    Date of Event
    June 28, 2014
    Report Date
    July 16, 2014
    Manufacturer
    ALLERGAN
    Product Code
    LMH
    PMA / PMN Number
    P110033
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    FURTHER INFORMATION FROM THE REPORTER REGARDING EVENT, PRODUCT, OR PATIENT DETAILS HAVE BEEN REQUESTED. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. THE EVENTS OF EDEMA AND "BACTERIO ONGOING FOR PUS" ARE PHYSIOLOGICAL COMPLICATIONS AND ANALYSIS OF THE DEVICE GENERALLY DOES NOT ASSIST ALLERGAN IN DETERMINING A PROBABLE CAUSE FOR THESE EVENTS. 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 PHYSIOCHEMICAL AND MICROBIOLOGICAL RESULTS (ENDOTOXINS, BIOBURDEN) ARE REGISTERED AS CONFORMING TO THE SPECIFICATIONS. THE STERILIZATION CYCLE IS REGISTERED AS CONFORMING.

    Description of Event or Problem · 1

    HEALTHCARE PROFESSIONAL REPORTED 8 DAYS AFTER INJECTION OF .5ML OF JUVEDERM VOLUMA WITH LIDOCAINE IN EACH CHEEKBONE, THE PATIENT DEVELOPED "IMPORTANT OEDEMA ON BOTH CHEEKS". PATIENT ADDITIONALLY DEVELOPED "BACTERIO ONGOING FOR PUS". PATIENT WAS TREATED WITH "PROFENID THEN GIBENINE" AND UNDERWENT A "PUS EXSUDATION BY SURGEON". PATIENT WAS ADDITIONALLY TREATED WITH ORBENINE WHICH COINCIDED WITH THE REAPPEARANCE OF SYMPTOMS AND WAS THEREFORE REPLACED WITH "DOXY", "ZECLAR", AND SOLUPRED. SYMPTOMS ARE ONGOING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    587670 JUVEDERM VOLUMA WITH LIDOCAINE 1ML SKU1 LMH ALLERGAN NA VB20A30298

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention PROPANOLO| KARDEGIC| COMEPRAZOLE