BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VOLLURE (VOLUME UNKNOWN)

    MDR report key: 20195049 · Received September 11, 2024

    Report

    Report Number
    3005113652-2024-00546
    Event Type
    Injury
    Date Received
    September 11, 2024
    Date of Event
    August 22, 2024
    Report Date
    September 11, 2024
    Manufacturer
    PRINGY
    Product Code
    LMH
    PMA / PMN Number
    P110033
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CLARIFICATION TO H.6. TYPE OF INVESTIGATION CODE: THE FILLER WAS INJECTED INTO THE PATIENT AND IS NOT ACCESSIBLE FOR RETURN. THE SYRINGE WAS NOT RETURNED FOR EVALUATION. FURTHER INFORMATION REGARDING EVENT, PRODUCT, OR PATIENT DETAILS HAS BEEN REQUESTED. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. THE EVENT 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 · 0

    HEALTHCARE PROFESSIONAL REPORTED INJECTING A PATIENT WITH 1CC OF JUVÉDERM® VOLLURE¿ XC. APPROXIMATELY 5 MONTHS LATER, PATIENT IS PRESENTING WITH INFLAMMATORY REACTION, LIPS WERE HARD AND SWOLLEN. PATIENT WAS TREATED WITH MEDROL DOSE PACK WITH SYMPTOMS IMPROVED BUT RE-OCCURRED. PREDNISOLONE WAS PRESCRIBED AND REACTION IMPROVED AGAIN, BUT AFTER TAPERING, IT GOT WORSE. PATIENT WAS TREATED WITH HYLENEX WITH NO IMPROVEMENTS. PATIENT IS ALSO TAKING AMOXICILLIN FOR A DIFFERENT REASON. SYMPTOMS ARE ON-GOING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    622889 VOLLURE (VOLUME UNKNOWN) IMPLANT, DERMAL, FOR AESTHETIC USE LMH PRINGY NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention| R