BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VOLIFT WITH LIDOCAINE

    MDR report key: 6735408 · Received July 24, 2017

    Report

    Report Number
    3005113652-2017-00733
    Event Type
    Injury
    Date Received
    July 24, 2017
    Date of Event
    June 2, 2017
    Report Date
    July 22, 2017
    Manufacturer
    ALLERGAN (PRINGY)
    Product Code
    LMH
    PMA / PMN Number
    P110033
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    FURTHER INFORMATION FROM THE REPORTER REGARDING EVENT HAS BEEN REQUESTED. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. THE EVENTS OF NODULES, STIFFNESS, SWELLING, AND PRODUCT FELT HARDER ARE PHYSIOLOGICAL COMPLICATIONS AND ANALYSIS OF THE DEVICE GENERALLY DOES NOT ASSIST ALLERGAN IN DETERMINING A PROBABLE CAUSE FOR THESE EVENTS. DEVICE LABELING FOR THE REPORTED EVENTS OF SKIN IRRITATION AND EDEMA: "UNDESIRABLE EFFECTS: THE PATIENTS MUST BE INFORMED THAT THERE ARE POTENTIAL SIDE EFFECTS ASSOCIATED WITH IMPLANTATION OF THIS PRODUCT, WHICH MAY OCCUR IMMEDIATELY OR MAY BE DELAYED. THESE INCLUDE, BUT ARE NOT LIMITED TO: INFLAMMATORY REACTIONS (REDNESS, OEDEMA, ERYTHEMA, ETC.) WHICH MAY BE ASSOCIATED WITH ITCHING AND/OR PAIN ON PRESSURE AND/OR PARESTHESIA, OCCURRING AFTER THE INJECTION. THESE REACTIONS MAY LAST FOR A WEEK. BESIDES, A PREVENTIVE ANTI-INFLAMMATORY TREATMENT BY A MEDICAL PRACTITIONER CAN BE RECOMMENDED. INDURATION OR NODULES AT THE INJECTION SITE."

    Description of Event or Problem · 1

    HEALTHCARE PROFESSIONAL REPORTED INJECTING A PATIENT WITH JUVÉDERM® VOLIFT¿ WITH LIDOCAINE IN THE UPPER AND LOWER LIPS. ON THE FOLLOWING MONTH THE PATIENT HAD A DENTAL CLEANING. ABOUT A WEEK AFTER THAT, THE PATIENT HAD DEVELOPED NODULES AT THE INJECTION SITES. THE PATIENT HAD STIFFNESS AND SWELLING ON ONE SIDE OF UPPER LIP THAT WAS DOUBLE IN SIZE OF THE OTHER SIDE. THE LIP IS "NOT ROCK HARD, PRODUCT FELT HARDER BUT SOMEWHAT MOLDABLE. PATIENT WAS TREATED WITH PREDNISONE AND CLAVULIN. SYMPTOMS ARE ONGOING. PATIENT WAS CONCOMITANTLY TAKING BIRTH CONTROL PILLS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    517371 VOLIFT WITH LIDOCAINE IMPLANT, DERMAL, FOR AESTHETIC USE LMH ALLERGAN (PRINGY) V17LA60203

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Required Intervention BIRTH CONTROL PILLS