BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VOLIFT WITH LIDOCAINE

    MDR report key: 11555756 · Received March 23, 2021

    Report

    Report Number
    3005113652-2021-00152
    Event Type
    Injury
    Date Received
    March 23, 2021
    Date of Event
    September 15, 2020
    Report Date
    May 28, 2021
    Manufacturer
    ALLERGAN (PRINGY)
    Product Code
    LMH
    PMA / PMN Number
    P110033
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 0

    ADDITIONALLY, IT WAS REPORTED THAT THE PATIENT WAS TREATED WITH HYALASE AND WAS GIVEN ANTIBIOTICS. THE PATIENT HAD SOME IMPROVEMENT. A SECOND HYALASE TREATMENT IMPROVED THE SIZE OF THE NODULES. ANTIBIOTICS WERE CEASED AND THE PATIENT WILL BE OBSERVED PRIOR TO STARTING INTRALESIONAL STEROIDS. THE EVENT IS ONGOING.

    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. A REVIEW OF THE DEVICE HISTORY RECORD HAS BEEN COMPLETED. NO DEVIATIONS OR NON-CONFORMANCES NOTED. THIS IS A KNOWN POTENTIAL ADVERSE EVENT ADDRESSED IN THE PRODUCT LABELING.

    Description of Event or Problem · 1

    HEALTH PROFESSIONAL REPORTED INJECTING A PATIENT IN THE LIPS WITH 1 ML OF JUVÉDERM® VOLIFT® WITH LIDOCAINE. THE PATIENT WAS PRETREATED WITH LMX 4. THREE YEARS LATER, THE PATIENT DEVELOPED ¿LUMPS¿ IN THE LIPS, ABOVE THE LIPS, AND LATERAL CHEEKS. THE FILLER MIGRATED AND PATIENT DEVELOPED GRANULOMAS. A BIOPSY PERFORMED BY A MAX FACIAL SURGEON 20 DAYS LATER NOTED ¿FLORID FOREIGN BODY TYPE GRANULOMATOUS INFLAMMATION POSSIBLY SECONDARY TO EXOGENOUS MATERIAL.¿ HYALASE (+/- STEROID INJECTION) TREATMENT HAS BEEN PLANNED ¿TO SEE IF ANY RESIDUE PRODUCT REMAINS WHICH COULD BE DISSOLVED¿ BUT NO TREATMENT WAS CONFIRMED. THE EVENT IS ONGOING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    453826 VOLIFT WITH LIDOCAINE IMPLANT, DERMAL, FOR AESTHETIC USE LMH ALLERGAN (PRINGY) V17LA70130

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR LMX 4, OMEPRAZOLE, LISINOPRIL| LMX 4, OMEPRAZOLE, LISINOPRIL