BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VOLIFT WITH LIDOCAINE

    MDR report key: 8633582 · Received May 22, 2019

    Report

    Report Number
    3005113652-2019-00405
    Event Type
    Injury
    Date Received
    May 22, 2019
    Date of Event
    April 17, 2019
    Report Date
    May 22, 2019
    Manufacturer
    ALLERGAN (PRINGY)
    Product Code
    LMH
    PMA / PMN Number
    P110033
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    FURTHER INFORMATION 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. THIS IS A KNOWN POTENTIAL ADVERSE EVENT ADDRESSED IN THE PRODUCT LABELING.

    Description of Event or Problem · 1

    HEALTHCARE PROFESSIONAL REPORTS THE EVENT OF "MOTTLED AND PURPLE SKIN SUGGESTIVE OF VASCULAR EVENT IN THE REGION AND ADJACENT AREAS SUCH AS 1/2 OF THE NOSE AND CHEEK¿ IMMEDIATELY AFTER 1 ML JUVÉDERM® VOLIFT¿ WITH LIDOCAINE INJECTION TO THE NASOLABIAL FOLD. TREATMENT INCLUDED WARM COMPRESSES, CORTICOID AND ANTIBIOTIC PROVIDED AFTER 8 HOURS OF SYMPTOMS EVOLUTION. HYALURONIDASE ADMINISTERED AFTER 24 HOURS [OF SYMPTOMS EVOLUTION]. SYMPTOMS ARE ONGOING AT THIS TIME. EVENT CAUSED A NON AESTHETIC AND EXTENSIVE LESION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    424650 VOLIFT WITH LIDOCAINE IMPLANT, DERMAL, FOR AESTHETIC USE LMH ALLERGAN (PRINGY) V17LA80439

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Required Intervention CORTICOID 40 MG