BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VOLLURE (VOLUME UNKNOWN)

    MDR report key: 8316687 · Received February 7, 2019

    Report

    Report Number
    3005113652-2019-00123
    Event Type
    Injury
    Date Received
    February 7, 2019
    Date of Event
    August 22, 2018
    Report Date
    February 7, 2019
    Manufacturer
    ALLERGAN (PRINGY)
    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

    FURTHER INFORMATION REGARDING EVENT, PRODUCT, OR PATIENT DETAILS HAS BEEN REQUESTED. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. THE EVENT OF "NODULE FORMATION" IS A PHYSIOLOGICAL COMPLICATION AND ANALYSIS OF THE DEVICE GENERALLY DOES NOT ASSIST ALLERGAN IN DETERMINING A PROBABLE CAUSE FOR THIS EVENT. THIS IS A KNOWN POTENTIAL ADVERSE EVENT ADDRESSED IN THE PRODUCT LABELING.

    Description of Event or Problem · 1

    HEALTHCARE PROFESSIONAL REPORTED A PATIENT WAS INJECTED IN THE CHEEKS, NASOLABIAL FOLDS, LIPS, AND THE MELOLABIAL FOLDS WITH 2CC OF JUVÉDERM VOLUMA® XC, 3CC OF JUVÉDERM VOLLURE¿ XC, AND 1 CC OF JUVÉDERM VOLBELLA® XC. IT WAS NOT SPECIFIED WHICH FILLER WAS INJECTED INTO WHAT AREA. SEVEN MONTHS LATER, THE PATIENT DEVELOPED A ¿NODULE FORMATION.¿ THE PATIENT WAS TREATED TWO WEEKS LATER WITH PREDNISONE AND HYLENEX AND AGAIN TWO WEEKS LATER, 16 DAYS LATER, AND 6 DAYS LATER. THE PHYSICIAN STATED THAT THEY GAVE THE PATIENT ¿PREDNISONE FOR 16 DAYS AND HYLENEX FOR FIRST SEVERAL APPOINTMENTS THEN HYLENEX AND 1 LC.¿ THE SYMPTOMS FULLY RESOLVED APPROXIMATELY 10 MONTHS POST INJECTION. THIS IS THE SAME EVENT AND THE SAME PATIENT REPORTED UNDER MDR ID # 3005113652-2019-00121 (ALLERGAN COMPLAINT # (B)(4)) AND MDR ID # 3005113652-2019-00124 (ALLERGAN COMPLAINT # (B)(4)) JUVÉDERM VOLBELLA® XC. THIS IS THE FIRST MDR SUBMITTED FOR THE SECOND SUSPECT PRODUCT, JUVÉDERM VOLLURE¿ XC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    108502 VOLLURE (VOLUME UNKNOWN) IMPLANT, DERMAL, FOR AESTHETIC USE LMH ALLERGAN (PRINGY) NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention JUVÉDERM VOLBELLA® XC, JUVÉDERM VOLUMA® XC