BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JUVEDERM VOLBELLA XC 2 X 1ML 32G

    MDR report key: 14136275 · Received April 18, 2022

    Report

    Report Number
    3005113652-2022-00227
    Event Type
    Injury
    Date Received
    April 18, 2022
    Date of Event
    January 14, 2022
    Report Date
    May 22, 2022
    Manufacturer
    ALLERGAN (PRINGY)
    Product Code
    LMH
    UDI-DI
    10888628043541
    PMA / PMN Number
    P110033
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). 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. THE FILLER WAS INJECTED INTO THE PATIENT AND IS NOT ACCESSIBLE FOR RETURN. THE SYRINGE WAS DISCARDED. 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. THE EVENT OF ¿INDICATIVE OF AUTOIMMUNE DISEASE I.E. SLE/RHEUMATOID," DEEMED NOT DEVICE RELATED IS CONSIDERED AN UNEXPECTED ADVERSE DRUG EXPERIENCE.

    Additional Manufacturer Narrative · 0

    ADDITIONAL, CHANGED, AND/OR CORRECTED DATA: H.6. A REVIEW OF THE DEVICE HISTORY RECORD HAS BEEN COMPLETED. NO DEVIATIONS OR NON-CONFORMANCES NOTED.

    Description of Event or Problem · 0

    PATIENT REPORTED THAT THEY WERE INJECTED WITH 0.7 CC OF JUVÉDERM VOLBELLA® XC INTO THE VERMILLION LIPS / VERTICAL LIP LINES. HEALTHCARE PROFESSIONAL REPORTED THAT PATIENT EXPERIENCED A ¿DELAYED ONSET NODULES¿ AT ¿LIPS/LIP LINES/UNDER EYES" NINE MONTHS AFTER INJECTION. DIAGNOSTIC TESTS OF GBC, CMP, DNA (DS) ANTIBODY, RNP ANTI, SM ANTI, ANA W/ REFLEX¿ PERFORMED WITH RESULTS NOTING "INDICATIVE OF AUTOIMMUNE DISEASE; I.E. SLE/RHEUMATOID," DEEMED NOT RELATED TO THE DEVICE. PATIENT WAS TREATED WITH HYALURONIDASE (INTRADERMAL) FOUR TIMES SINCE ONSET OF EVENT. SYMPTOMS HAVE NOT BEEN RESOLVED.

    Description of Event or Problem · 0

    PATIENT REPORTED THAT THEY WERE INJECTED WITH 0.7 CC OF JUVÉDERM VOLBELLA® XC INTO THE VERMILLION LIPS / VERTICAL LIP LINES. HEALTHCARE PROFESSIONAL REPORTED THAT PATIENT EXPERIENCED A ¿DELAYED ONSET NODULES¿ AT ¿LIPS/LIP LINES/UNDER EYES" NINE MONTHS AFTER INJECTION. DIAGNOSTIC TESTS OF GBC, CMP, DNA (DS) ANTIBODY, RNP ANTI, SM ANTI, ANA W/ REFLEX¿ PERFORMED WITH RESULTS NOTING "INDICATIVE OF AUTOIMMUNE DISEASE; I.E. SLE/RHEUMATOID," DEEMED NOT RELATED TO THE DEVICE. PATIENT WAS TREATED WITH HYALURONIDASE (INTRADERMAL) FOUR TIMES SINCE ONSET OF EVENT. SYMPTOMS HAVE NOT BEEN RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2716953 JUVEDERM VOLBELLA XC 2 X 1ML 32G IMPLANT, DERMAL, FOR AESTHETIC USE LMH ALLERGAN (PRINGY) V15LB00860 10888628043541

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Female Required Intervention