BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JUVEDERM VOLUMA XC/LIDO (VOLUME UNK

    MDR report key: 3971274 · Received June 30, 2014

    Report

    Report Number
    3005113652-2014-00291
    Event Type
    Injury
    Date Received
    June 30, 2014
    Date of Event
    March 26, 2014
    Report Date
    June 2, 2014
    Manufacturer
    ALLERGAN
    Product Code
    LMH
    PMA / PMN Number
    P110033
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    MEDWATCH SENT TO FDA ON (B)(4) 2014. FURTHER INFO HAS BEEN REQUESTED. NO ADD'L INFO IS AVAILABLE AT THIS TIME. ALLERGAN IS UNABLE TO CONFIRM WITH THE HEALTHCARE PROFESSIONAL, THEREFORE ADD'L EVENT, PRODUCT, OR PT DETAILS ARE NOT ATTAINABLE. THE EVENT OF A "THIN BUMP" THAT "PUFFED UP" IS 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

    PT REPORTED AFTER INJECTION IN THE CHEEKS WITH UNSPECIFIED JUVEDERM VOLUMA XC, THEY DEVELOPED A "THIN BUMP" THAT "PUFFED UP" UNDER THE LEFT EYE CLOSER TO THE NOSE. THE SAME DATE OF INJECTION AND SUBSEQUENTLY ONSET OF PT SYMPTOMS, THE INJECTING HEALTHCARE PROFESSIONAL INFORMED THE PT THAT THE "THIN BUMP" THAT "PUFFED UP" UNDER THE LEFT EYE WAS A VEIN. THE PT REPORTED HAVING ADD'L JUVEDERM VOLUMA XC INJECTED 3 DAYS AFTER ONSET OF SYMPTOMS WITH NO COMPLAINT NOR WORSENING OF SYMPTOMS SUBSEQUENT TO THAT INJECTION. TWO MONTHS AFTER SYMPTOM ONSET, THE PT WAS EVALUATED BY ANOTHER HEALTHCARE PROFESSIONAL WHO PRESCRIBED AN INJECTION OF "A PRODUCT THAT DISSOLVES" JUVEDERM VOLUMA XC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    378788 JUVEDERM VOLUMA XC/LIDO (VOLUME UNK LMH ALLERGAN NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention