BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JUVEDERM VOLUMA XC/LIDO (VOLUME UNKNOWN)

    MDR report key: 15557691 · Received October 6, 2022

    Report

    Report Number
    3005113652-2022-00665
    Event Type
    Injury
    Date Received
    October 6, 2022
    Date of Event
    October 15, 2021
    Report Date
    October 6, 2022
    Manufacturer
    ALLERGAN (PRINGY)
    Product Code
    LMH
    PMA / PMN Number
    P110033
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    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 PATIENT WAS INJECTED AT ANOTHER HOSPITAL WITH 4 CC OF JUVEDERM VISTA VOLUMA XC, 2CC OF JUVEDERM VISTA VOLUX XC AND 1CC OF JUVEDERM VISTA VOLBELLA XC. FOUR MONTHS AFTER INJECTION, A LUMP APPEARED AROUND THE CHIN. TWO WEEKS LATER, LUMPS APPEARED ON THE ENTIRE CHIN, TEMPLES, CHEEKS, AND LIPS . HCP REPORTED SYMPTOMS OF HOT, SWELLING, AND EDEMA WERE PRESENT. HCP TREATED WITH SOLCORTEF 300 MG X 5 DAYS, 200 MG X 2 DAYS AND SYMPTOMS DID NOT IMPROVE. HCP AGAIN ADMINISTERED 300 MG X 3 DAYS, THEN 200 MG X 1 DAY, 100 MG X 1 DAY. AFTER THAT, PATIENT WAS PRESCRIBED PREDNISONE 10MG, ANTI-ALLERGIC AGENT, FUROSEMIDE, ANTIBIOTICS, AND GOREISAN WERE ADMINISTERED FOR ONE MONTH. PATIENT WAS ALSO TREATED WITH HYALURONIDASE INJECTION. SEVERAL MONTHS LATER, SYMPTOMS COMPLETELY RESOLVED. THIS IS THE SAME EVENT AND THE SAME PATIENT REPORTED UNDER MDR ID# 3005113652-2022-00666 (ALLERGAN COMPLAINT #(B)(4), MDR ID# 3005113652-2022-00667 (ALLERGAN COMPLAINT #(B)(4). THIS MDR IS BEING SUBMITTED FOR THE FIRST SUSPECT PRODUCT, JUVEDERM VISTA VOLUMA XC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2395029 JUVEDERM VOLUMA XC/LIDO (VOLUME UNKNOWN) IMPLANT, DERMAL, FOR AESTHETIC USE LMH ALLERGAN (PRINGY) NI

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Female Required Intervention JUVEDERM VISTA VOLUX XC, VISTA VOLBELLA XC