BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK JUVEDERM VOLUX

    MDR report key: 17102245 · Received June 10, 2023

    Report

    Report Number
    3005113652-2023-00453
    Event Type
    Injury
    Date Received
    June 10, 2023
    Date of Event
    May 8, 2023
    Report Date
    June 10, 2023
    Manufacturer
    ALLERGAN (PRINGY)
    Product Code
    LMH
    PMA / PMN Number
    P110033
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    NURSE
    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. THE EVENT IS A PHYSIOLOGICAL COMPLICATION AND ANALYSIS OF THE DEVICE GENERALLY DOES NOT ASSIST ABBVIE IN DETERMINING A PROBABLE CAUSE FOR THIS EVENT. FURTHER INFORMATION 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 · 0

    HEALTHCARE PROFESSIONAL (HCP) REPORTED A PATIENT WAS INJECTED IN THE CHIN WITH JUVÉDERM VOLUMA® XC, AND IN THE JAWLINE WITH JUVÉDERM VOLUX¿, AND IN THE ORAL COMMISSURES WITH JUVÉDERM® ULTRA PLUS XC. THIRTEEN DAYS LATER THE PATIENT EXPERIENCED ¿SWELLING WARMTH AND ABSCESS AND CRUSTING OF SKIN ON LEFT SIDE OF FACE AND EARLY ONSET NODULE¿. PATIENT WAS TREATED WITH BACTRIM WITH MARGINAL IMPROVEMENT BUT WENT TO PCP WHO INCREASED DOSAGE. AFTER 5 DAYS ON HIGHER DOSE, CONDITION WORSENED. EVENTS ARE ONGOING. THIS IS THE SAME EVENT AND THE SAME PATIENT REPORTED UNDER MDR ID# 3005113652-2023-00427 (ABBVIE COMPLAINT #PR (B)(4)), AND MDR ID# 3005113652-2023-00428 (ABBVIE COMPLAINT #PR 2780038). THIS MDR IS BEING SUBMITTED FOR THE SUSPECT PRODUCT, JUVÉDERM VOLUX¿.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2270944 UNK JUVEDERM VOLUX IMPLANT, DERMAL, FOR AESTHETIC USE LMH ALLERGAN (PRINGY) NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention JUVÉDERM VOLUMA® XC, JUVÉDERM® ULTRA PLUS XC.