BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VOLIFT WITH LIDOCAINE

    MDR report key: 11660205 · Received April 13, 2021

    Report

    Report Number
    3005113652-2021-00217
    Event Type
    Injury
    Date Received
    April 13, 2021
    Date of Event
    December 31, 2020
    Report Date
    July 14, 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

    Additional Manufacturer Narrative · 0

    A REVIEW OF THE DEVICE HISTORY RECORD HAS BEEN INITIATED. IF ANY NEW, CHANGED OR CORRECTED INFORMATION IS NOTED, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    A REVIEW OF THE DEVICE HISTORY RECORD HAS BEEN COMPLETED. NO DEVIATIONS OR NON-CONFORMANCES NOTED.

    Description of Event or Problem · 0

    ADDITIONALLY, THE HEALTH PROFESSIONAL REPORTED INJECTING A PATIENT IN THE CK1, CK2, AND SUB-ZYGOMA WITH JUVÉDERM® VOLUMA¿ WITH LIDOCAINE AND IN THE MARIONETTE REGION AND ORAL COMMISSURES WITH JUVÉDERM® VOLIFT¿ WITH LIDOCAINE. THE PATIENT WAS PRETREATED WITH LMX CREAM. APPROXIMATELY 3 WEEKS POST-INJECTION, THE PATIENT DEVELOPED ¿GI SYMPTOMS (DIARRHEA),¿ DEEMED NOT RELATED TO THE INJECTINS, THEN DEVELOPED ¿DISCOMFORT AND SWELLING¿ IN THE CHIN AREA AND ¿MILD DISCOMFORT¿ IN THE CHEEKS. THE PATIENT WAS TREATED WITH CLARITHROMYCIN AND STEROIDS. THE PATIENT DECIDED NOT TO DISSOLVE AS SYMPTOMS HAVE IMPROVED SIGNIFICANTLY AFTER 5 WEEKS.

    Description of Event or Problem · 0

    ADDITIONALLY, THE HEALTH PROFESSIONAL REPORTED THAT THE EVENT RESOLVED 5 MONTHS POST-ONSET.

    Additional Manufacturer Narrative · 1

    FURTHER INFORMATION REGARDING EVENT, PRODUCT, OR PATIENT DETAILS HAS BEEN REQUESTED. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. THE EVENT IS A PHYSIOLOGICAL COMPLICATION AND ANALYSIS OF THE DEVICE GENERALLY DOES NOT ASSIST ALLERGAN IN DETERMINING A PROBABLE CAUSE FOR THIS EVENT. 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

    HEALTHCARE PROFESSIONAL (HCP) REPORTS PATIENT INJECTION WITH 2ML JUVÉDERM VOLUMA AND 1ML JUVÉDERM VOLIFT. PATIENT DEVELOPED A DELAYED INFLAMMATORY RESPONSE. HCP FURTHER STATES, PATIENTS SYMPTOMS SETTLED SIGNIFICANTLY 5 WEEKS AFTER TREATMENT WITH ANTIBIOTICS AND STEROIDS. PATIENT IS LEFT WITH SOME RESIDUAL SMALL LUMPS EITHER SIDE OF THEIR CHIN BUT FEELS THEY ARE GOING DOWN SO WE ARE GOING TO CONTINUE TO OBSERVE. THIS IS THE SAME EVENT AND THE SAME PATIENT REPORTED UNDER MDR ID# 3005113652-2021-00216 ALLERGAN COMPLAINT #(B)(4). THIS MDR IS BEING SUBMITTED FOR THE JUVÉDERM VOLIFT INJECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    556033 VOLIFT WITH LIDOCAINE IMPLANT, DERMAL, FOR AESTHETIC USE LMH ALLERGAN (PRINGY) V17LA90409

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention JUVÉDERM® VOLUMA¿| LMX CREAM