BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VOLIFT WITH LIDOCAINE

    MDR report key: 6691328 · Received July 6, 2017

    Report

    Report Number
    3005113652-2017-00678
    Event Type
    Injury
    Date Received
    July 6, 2017
    Date of Event
    June 7, 2017
    Report Date
    August 11, 2017
    Manufacturer
    ALLERGAN (PRINGY)
    Product Code
    LMH
    PMA / PMN Number
    P110033
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FURTHER INFORMATION FROM THE REPORTER REGARDING THE EVENT, PRODUCT, OR PATIENT DETAILS HAS BEEN REQUESTED. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. THE EVENT OF ¿NODULES¿ IS A PHYSIOLOGICAL COMPLICATION AND ANALYSIS OF THE DEVICE GENERALLY DOES NOT ASSIST ALLERGAN IN DETERMINING A PROBABLE CAUSE FOR THIS EVENT. DEVICE LABELING ADDRESSES THE REPORTED EVENTS AS FOLLOWS: 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: INDURATION OR NODULES AT THE INJECTION SITE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION: HEALTHCARE PROFESSIONAL REPORT INJECTING A PATIENT WITH JUVÉDERM® VOLIFT¿ WITH LIDOCAINE IN THE MARIONETTE LINES AND NASAL JUGAL GROOVE. ABOUT 12 MONTHS LATER, THE PATIENT HAD SOME DENTAL WORK DONE. A COUPLE OF WEEKS LATER, THE PATIENT DEVELOPED NODULES ON THE RIGHT CHIN AND INJECTION SITES. PATIENT WAS TREATED WITH CIPROFLOXACIN, AMOXICILLIN AND SEVERAL INJECTIONS WITH HYALURONIDASE OVER THE NEXT MONTH. PATIENT ALSO HAD A PLATELET RICH PLASMA INJECTION INTO THE CHIN AND MEDIAL CHEEKS. A WEEK LATER, THE PATIENT DEVELOPED A NEW NODULE ON THE CHIN AND WAS AGAIN TREATED WITH HYALURONIDASE. SYMPTOMS ARE ONGOING.

    Description of Event or Problem · 1

    CLINIC MANAGER REPORTED THAT APPROXIMATELY 15 MONTHS AFTER INJECTION WITH ONE SYRINGE OF JUVÉDERM® VOLIFT¿ WITH LIDOCAINE ¿AROUND THE MOUTH¿ PATIENT DEVELOPED NODULES. THE PATIENT HAD JUST HAD DENTAL WORK AND THE NODULES APPEARED. NO TREATMENT NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    470816 VOLIFT WITH LIDOCAINE IMPLANT, DERMAL, FOR AESTHETIC USE LMH ALLERGAN (PRINGY) V17LA50285

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR