BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VOLIFT WITH LIDOCAINE

    MDR report key: 8875734 · Received August 8, 2019

    Report

    Report Number
    3005113652-2019-00589
    Event Type
    Injury
    Date Received
    August 8, 2019
    Date of Event
    June 19, 2019
    Report Date
    February 18, 2020
    Manufacturer
    ALLERGAN (PRINGY)
    Product Code
    LMH
    PMA / PMN Number
    P110033
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PE
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL DATA: B.5, C., G.1

    Description of Event or Problem · 0

    HEALTHCARE PROFESSIONAL REPORTS THAT "EVERYTHING WAS RESOLVED SATISFACTORILY AND WITHOUT SEQUEL."

    Additional Manufacturer Narrative · 1

    (B)(4). 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. 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

    HEALTHCARE PROFESSIONAL REPORTS PATIENT INJECTION WITH 1 ML JUVÉDERM¿ VOLUMA¿ WITH LIDOCAINE IN CK1, CK2, CK3 (MALAR) AND 1 ML JUVÉDERM¿ VOLIFT¿ WITH LIDOCAINE IN CK3 (MALAR), NASOLABIAL FOLDS, LP1 AND LP2 (LIPS). ABOUT 2 WEEKS LATER, 0.5 ML OF JUVÉDERM¿ VOLIFT¿ WITH LIDOCAINE WAS APPLIED. HEADACHE EXPERIENCED 2 DAYS LATER. THREE WEEKS LATER, PATIENT BEGAN TO SWELL IN THE FACE AND EXPERIENCED STRONG HEADACHE, PAIN, HYPOTENSION AND PRODUCT ACCUMULATION/NODULE FORMATION IN LOWER EYELID AND INJECTION SITES. PATIENT¿S BLOOD PRESSURE IS AT 90/50 AND PHYSICIAN IS WORRIED. REMOTE EVALUATION BY VIDEOCONFERENCE TOOK PLACE AS PATIENT LIVES ABROAD. PATIENT TOOK PREDNISONE 5MG, ORAL PER 4 DAYS AND THE SWELLING AND HEADACHE DECREASED, HOWEVER THE ¿BALLS¿ HAVE REMAINED. TREATMENT DISCONTINUED FOR 3 DAYS AND RESTARTED ABOUT ONE MONTH AFTER SECOND INJECTION. SYMPTOMS ARE ONGOING AT THIS TIME, AND ARE GETTING WORSE.THIS IS THE SAME EVENT AND THE SAME PATIENT REPORTED UNDER MDR ID# 3005113652-2019-00588 (ALLERGAN COMPLAINT #1943969) AND MDR ID# 3005113652-2019-00590 (ALLERGAN COMPLAINT #1944240). THIS MDR IS BEING SUBMITTED FOR THE FIRST INJECTION OF JUVÉDERM¿ VOLIFT¿ WITH LIDOCAINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    670288 VOLIFT WITH LIDOCAINE IMPLANT, DERMAL, FOR AESTHETIC USE LMH ALLERGAN (PRINGY) V17LA80640

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Life Threatening| R LEVOTHYROXINE, JUVÉDERM¿ VOLUMA¿ WITH LIDOCAINE