BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JUVEDERM VOLLURE XC 2X1 ML

    MDR report key: 17882137 · Received October 5, 2023

    Report

    Report Number
    3005113652-2023-00791
    Event Type
    Injury
    Date Received
    October 5, 2023
    Date of Event
    September 15, 2023
    Report Date
    October 5, 2023
    Manufacturer
    ALLERGAN (PRINGY)
    Product Code
    LMH
    UDI-DI
    10888628034471
    PMA / PMN Number
    P110033
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN ASSISTANT
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CLARIFICATION TO SECTION C. SUSPECT PRODUCT: LOT NUMBER: 963/3. CONTINUED H.6. TYPE OF INVESTIGATION CODE: B15, B18, B20. CLARIFICATION TO H.6. TYPE OF INVESTIGATION CODE: THE FILLER WAS INJECTED INTO THE PATIENT AND IS NOT ACCESSIBLE FOR RETURN. THE SYRINGE HAS BEEN DISCARDED. 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. A REVIEW OF THE DEVICE HISTORY RECORD HAS BEEN INITIATED. IF ANY NEW, CHANGED OR CORRECTED INFORMATION IS NOTED, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED.

    Description of Event or Problem · 0

    HEALTHCARE PROFESSIONAL REPORTED THAT A PATIENT WAS INJECTED 0.5 ML OF JUVÉDERM VOLBELLA® XC IN THE LIPS AND 1 ML OF OF JUVÉDERM® VOLLURE¿ XC IN THE MARIONETTE LINES AND NASOLABIAL FOLDS. FOUR MONTHS LATER, PATIENT EXPERIENCED BUMP ON THE RIGHT LIP. TWO DAYS LATER, PATIENT REPORTED SWOLLEN ON LIP AND LOWER FACE. PATIENT WAS TREATED WITH MEDROL DOSE PACK. FIVE DAYS LATER, PATIENT WAS TREATED WITH 2 ML OF HYLENEX IN THE LIPS AND LOWER FACE. THE SYRINGE HAS BEEN DISCARDED. THE SYMPTOMS ARE ONGOING. THIS IS THE SAME EVENT AND THE SAME PATIENT REPORTED UNDER MDR ID# 3005113652-2023-00790 (ALLERGAN COMPLAINT #PR 2854863). THIS MDR IS BEING SUBMITTED FOR THE SUSPECT PRODUCT, JUVÉDERM VOLBELLA® XC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2099070 JUVEDERM VOLLURE XC 2X1 ML IMPLANT, DERMAL, FOR AESTHETIC USE LMH ALLERGAN (PRINGY) 1000539345 10888628034471

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Female Required Intervention