BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JUVEDERM VOLUMA WITH LIDOCAINE

    MDR report key: 11924841 · Received June 2, 2021

    Report

    Report Number
    3005113652-2021-00263
    Event Type
    Injury
    Date Received
    June 2, 2021
    Date of Event
    December 31, 2020
    Report Date
    June 2, 2021
    Manufacturer
    ALLERGAN (PRINGY)
    Product Code
    LMH
    PMA / PMN Number
    P110033
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). FURTHER INFORMATION FROM THE REPORTER REGARDING EVENT, PRODUCT, OR PATIENT DETAILS HAS BEEN REQUESTED. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. THE EVENTS ARE PHYSIOLOGICAL COMPLICATIONS AND ANALYSIS OF THE DEVICE GENERALLY DOES NOT ASSIST ALLERGAN IN DETERMINING A PROBABLE CAUSE FOR THESE EVENTS. THE FILLER WAS INJECTED INTO THE PATIENT AND IS NOT ACCESSIBLE FOR RETURN. THE SYRINGE WAS NOT RETURNED FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD HAS BEEN COMPLETED. NO DEVIATIONS OR NON-CONFORMANCES NOTED. THIS IS A KNOWN POTENTIAL ADVERSE EVENT ADDRESSED IN THE PRODUCT LABELING.

    Description of Event or Problem · 1

    HEALTH PROFESSIONAL REPORTED INJECTING A PATIENT IN THE CK1, CK2, AND SUB-ZYGOMA WITH 2 ML OF JUVÉDERM® VOLUMA¿ WITH LIDOCAINE AND IN THE MARIONETTE REGION AND ORAL COMMISSURES WITH 1 ML OF JUVÉDERM® VOLIFT¿ WITH LIDOCAINE. THE PATIENT WAS PRETREATED WITH LMX CREAM. APPROXIMATELY 3 WEEKS POST-INJECTION, THE PATIENT DEVELOPED ¿GI SYMPTOMS (DIARRHEA),¿ DEEMED NOT RELATED TO THE INJECTIONS, THEN DEVELOPED ¿DISCOMFORT AND SWELLING¿ IN THE CHIN AREA AND ¿MILD DISCOMFORT¿ IN THE CHEEKS. THE PATIENT EXPERIENCED A ¿DELAYED INFLAMMATORY RESPONSE.¿ THE PATIENT WAS TREATED WITH CLARITHROMYCIN AND STEROIDS. THE PATIENT DECIDED NOT TO DISSOLVE. SYMPTOMS IMPROVED SIGNIFICANTLY AFTER 5 WEEKS. THE PATIENT HAD ¿SOME RESIDUAL SMALL LUMPS¿ BILATERALLY ON THE CHIN BUT FELT LIKE THEY WERE GOING DOWN. THIS IS THE SAME EVENT AND THE SAME PATIENT REPORTED UNDER MDR ID# 3005113652-2021-00216 (ALLERGAN COMPLAINT # (B)(4)) AND MDR ID# 3005113652-2021-00217 (ALLERGAN COMPLAINT #(B)(4)). THIS MDR IS BEING SUBMITTED FOR THE SUSPECT PRODUCT, JUVÉDERM® VOLUMA¿ WITH LIDOCAINE (LOT: VB20B00344).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    818407 JUVEDERM VOLUMA WITH LIDOCAINE IMPLANT, DERMAL, FOR AESTHETIC USE LMH ALLERGAN (PRINGY) VB20B00344

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention