BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JUVEDERM VOLUMA WITH LIDOCAINE 1ML

    MDR report key: 11015592 · Received December 16, 2020

    Report

    Report Number
    3005113652-2020-00744
    Event Type
    Injury
    Date Received
    December 16, 2020
    Date of Event
    November 18, 2020
    Report Date
    January 12, 2021
    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 · 0

    A REVIEW OF THE DEVICE HISTORY RECORD HAS BEEN COMPLETED. NO DEVIATIONS OR NON-CONFORMANCES NOTED. CLARIFICATION TO SECTION H6: THE FILLER WAS INJECTED INTO THE PATIENT AND IS NOT ACCESSIBLE FOR RETURN. THE SYRINGE WAS DISCARDED.

    Description of Event or Problem · 0

    HEALTHCARE PROFESSIONAL REPORTED THAT A PATIENT WAS INJECTED WITH 3 ML OF JUVÉDERM¿ VOLUMA¿ WITH LIDOCAINE (1 ML PER CHEEK AND 1 ML IN THE CHIN). THE PATIENT EXPERIENCED SWELLING IN THE MIDDLE AND LEFT SIDE OF THE CHIN, INJECTION SITE. THE HCP SAW THE PATIENT ABOUT A YEAR LATER; PATIENT HAD ¿SWELLING, REDNESS AND HARD NODULES.¿ ¿FELT UNWELL A FEW DAYS PRIOR [MAYBE 2-3 DAYS], COULD HAVE BEEN TRIGGERED BY A FL[U] LIKE ILLNESS¿. ¿THE MAIN THING IS THAT THE UNWELL FEELING ? FLU LIKE SYMPTOMS PRECEDED THE LUMPS. AT WHICH POINT [PATIENT] CAME TO SEE [THE PHYSICIAN]¿. PATIENT WAS STARTED ON ANTIBIOTICS FOR 10 DAYS ON THE REPORTED DATE OF ONSET. THE PATIENT DID NOT WISH ANY OTHER INTERVENTIONS OR TO DISSOLVE THE PRODUCT. PATIENT WAS HAPPY WITH THE OUTCOME. THE SYMPTOMS RESOLVED 3 DAYS LATER WITH NO FURTHER INVESTIGATION AFTER THE ANTIBIOTICS.

    Additional Manufacturer Narrative · 1

    CLARIFICATION: THE FILLER WAS INJECTED INTO THE PATIENT AND IS NOT ACCESSIBLE FOR RETURN. THE SYRINGE WAS NOT RETURNED FOR EVALUATION. THE EVENT OF IS A PHYSIOLOGICAL COMPLICATION AND ANALYSIS OF THE DEVICE GENERALLY DOES NOT ASSIST ALLERGAN IN DETERMINING A PROBABLE CAUSE FOR THIS EVENT. FURTHER INFORMATION FROM THE REPORTER REGARDING EVENT, PRODUCT, OR PATIENT DETAILS HAS BEEN REQUESTED. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. THIS IS A KNOWN POTENTIAL ADVERSE EVENT ADDRESSED IN THE PRODUCT LABELING.

    Description of Event or Problem · 1

    HEALTHCARE PROFESSIONAL REPORTED THAT A PATIENT WAS INJECTED WITH JUVÉDERM¿ VOLUMA¿ WITH LIDOCAINE. THE PATIENT EXPERIENCED SWELLING IN THE CHIN WHERE THE PRODUCT WAS INJECTED. THE HCP SAW THE PATIENT A YEAR LATER; PATIENT HAS ¿SWELLING, REDNESS AND HARD NODULES.¿ THE EVENT IS ONGOING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1482500 JUVEDERM VOLUMA WITH LIDOCAINE 1ML IMPLANT, DERMAL, FOR AESTHETIC USE LMH ALLERGAN (PRINGY) VB20A90057

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention