BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JUVEDERM VOLUMA WITH LIDOCAINE 1ML SKU1

    MDR report key: 3932013 · Received June 20, 2014

    Report

    Report Number
    3005113652-2014-00307
    Event Type
    Injury
    Date Received
    June 20, 2014
    Date of Event
    March 20, 2014
    Report Date
    March 20, 2014
    Manufacturer
    ALLERGAN
    Product Code
    LMH
    PMA / PMN Number
    P110033
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    FURTHER INFORMATION FROM THE REPORTER REGARDING EVENT, PRODUCT, OR PT DETAILS HAS BEEN REQUESTED. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. THE EVENT OF A SMALL NODULE IS A PHYSIOLOGICAL COMPLICATION AND ANALYSIS OF THE DEVICE GENERALLY DOES NOT ASSIST ALLERGAN IN DETERMINING A PROBABLE CAUSE FOR THIS EVENT. DEVICE LABELING: UNDESIRABLE EFFECTS. THE PT MUST BE INFORMED THAT THERE ARE POTENTIAL SIDE EFFECTS ASSOCIATED WITH IMPLANTATION OF THIS PRODUCT, WHICH MAY OCCUR IMMEDIATELY OR MAY BE DELAYS. THESE INCLUDE BUT ARE NOT LIMITED TO: INDURATIONS OR NODULES AT THE INJECTION AREA.

    Description of Event or Problem · 1

    HEALTHCARE PROFESSIONAL REPORTED "A COUPLE OF HOURS" FOLLOWING INJECTION WITH JUVEDERM VOLUMA WITH LIDOCAINE IN THE MALAR CHEEK PAD THE PT DEVELOPED A SMALL NODULE ON THE RIGHT CHEEK. THE PT DID NOT REPORT THIS SYMPTOM TO THE HEALTHCARE PROFESSIONAL UNTIL APPROXIMATELY 9 MONTHS AFTER INJECTION. HE PT WAS TREATED WITH CIPROFLOXACIN AND HYALASE. PT SYMPTOMS RESOLVED IMMEDIATELY FOLLOWING TREATMENT WITH HYALASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    362424 JUVEDERM VOLUMA WITH LIDOCAINE 1ML SKU1 LMH ALLERGAN NA VB20A30013

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Required Intervention