BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VOLIFT (VOLUME UNKNOWN)

    MDR report key: 12096097 · Received June 30, 2021

    Report

    Report Number
    3005113652-2021-03058
    Event Type
    Injury
    Date Received
    June 30, 2021
    Date of Event
    May 30, 2021
    Report Date
    June 30, 2021
    Manufacturer
    ALLERGAN (PRINGY)
    Product Code
    LMH
    PMA / PMN Number
    P110033
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    HEALTH PROFESSIONAL REPORTED INJECTING A PATIENT INJECTED IN THE GOLGO LINE (NASOLABIAL FOLDS) WITH 1 CC OF JUVEDERM VISTA VOLIFT XC AND IN THE JW1, JW4, AND C2 (JAW AND CHIN) WITH 1.2 CC OF JUVEDERM VISTA VOLUX XC. THREE DAYS LATER, THE PATIENT EXPERIENCED A ¿NODULE, PAIN, REDNESS, ITCHING, AND SWELLING¿ AT THE JW4. UNSPECIFIED TREATMENT WAS PROVIDED. THE EVENT IS ONGOING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    989112 VOLIFT (VOLUME UNKNOWN) IMPLANT, DERMAL, FOR AESTHETIC USE LMH ALLERGAN (PRINGY) NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention