BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JUVEDERM VOLUMA WITH LIDOCAINE 1ML

    MDR report key: 3783969 · Received April 15, 2014

    Report

    Report Number
    3005113652-2014-00076
    Event Type
    Injury
    Date Received
    April 15, 2014
    Date of Event
    April 15, 2013
    Report Date
    February 6, 2014
    Manufacturer
    ALLERGAN
    Product Code
    LMH
    PMA / PMN Number
    P110033
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MEDWATCH SENT TO FDA ON (B)(4) 2014. THE EVENT OF AN INFECTION AND SUBSEQUENT DEVELOPMENT OF SCAR TISSUE IS A PHYSIOLOGICAL COMPLICATION AND ANALYSIS OF THE DEVICE GENERALLY DOES NOT ASSIST ALLERGAN IN DETERMINING A PROBABLE CAUSE FOR THIS EVENT.

    Description of Event or Problem · 1

    HEALTHCARE PROFESSIONAL REPORTED WITHIN 2 WEEKS OF INJECTION WITH JUVEDERM VOLUMA WITH LIDOCAINE IN THE CHEEKS, AS WELL AS JUVEDERM ULTRA XC IN THE CHEEKS AND NASOLABIAL FOLDS, THE PATIENT DEVELOPED AN INFECTION AND SCAR TISSUE AT THE RIGHT CHEEK. THE PATIENT RETURNED TO THE OFFICE APPROXIMATELY 2.5 WEEKS AFTER INJECTION AND THE HEALTHCARE PROFESSIONAL "DRAINED" THE SYMPTOM SITE. APPROXIMATELY 5 WEEKS LATER, THE PATIENT WAS PRESCRIBED KEFLEX AND RADIO FREQUENCY THERAPY TO HASTEN RESOLUTION OF SYMPTOMS. FOUR DAYS LATER, THE SYMPTOM SITE WAS DRAINED ONCE AGAIN; THE HEALTHCARE PROFESSIONAL CONSIDERED THE "DRAINAGE" TREATMENTS NECESSARY TO PREVENT PERMANENT DAMAGE. APPROXIMATELY 1 MONTH AFTER THE SECOND "DRAINAGE" TREATMENT, PATIENT SYMPTOMS RESOLVED. THIS IS THE SAME EVENT AND THE SAME PATIENT REPORTED UNDER MDR ID NUMBER 3005113652-2014-00056 (ALLERGAN COMPLAINT 1062537). THIS MDR IS BEING SUBMITTED FOR THE SECOND SUSPECT PRODUCT, JUVEDERM VOLUMA WITH LIDOCAINE, ALSO A DEVICE MANUFACTURED BY ALLERGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    230855 JUVEDERM VOLUMA WITH LIDOCAINE 1ML LMH ALLERGAN NA VB20A20162

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention OMEGA 3 SUPPLEMENT| JUVEDERM ULTRA XC| CALCIUM SUPPLEMENT