BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JUVEDERM VOLUMA WITH LIDOCAINE

    MDR report key: 11405143 · Received March 3, 2021

    Report

    Report Number
    3005113652-2021-00104
    Event Type
    Injury
    Date Received
    March 3, 2021
    Date of Event
    December 27, 2020
    Report Date
    June 3, 2021
    Manufacturer
    ALLERGAN (PRINGY)
    Product Code
    LMH
    PMA / PMN Number
    P110033
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    CLARIFICATION TO A.2.: YEAR OF BIRTH IS PROVIDED AS 1974. A REVIEW OF THE DEVICE HISTORY RECORD HAS BEEN INITIATED. IF ANY DEVIATIONS OR NON-CONFORMANCES ARE FOUND, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED. ADDITIONAL, CHANGED, AND/OR CORRECTED DATA: A.2., A.3., B.2., B.3., B.5., B.7., SECTION C., D.1, D.4, D.6A, D.10. H4., H6.

    Additional Manufacturer Narrative · 0

    CORRECTED DATA: B.3.

    Description of Event or Problem · 0

    ADDITIONALLY, THE HEALTH PROFESSIONAL REPORTED INJECTING THE PATIENT IN THE CHIN-CHEEKS WITH 3 ML. THE PATIENT WAS PRE-TREATED WITH EMLA CREAM AND RECEIVED A COOL PACK POST-INJECTION. APPROXIMATELY 1 WEEK POST-INJECTION, THE PATIENT EXPERIENCED ¿GRANULOMAS¿ ON THE CHEEKS AND CHIN ¿ JAWLINE (C2, JWS,-JWG). THE PATIENT WAS TREATED WITH 150 UNITS OF HYALASE AND ANOTHER 300 UNITS 3 WEEKS LATER. PER HEALTH PROFESSIONAL, "IMPROVEMENT FINAL RESULTS UNKNOWN."

    Description of Event or Problem · 0

    HEALTH PROFESSIONAL REPORTED INJECTING A PATIENT IN THE JAWLINE WITH JUVÉDERM® VOLUMA¿. THE PATIENT EXPERIENCED ¿KNOTS/GRANULOMA¿ AT THE INJECTION SITE. BIOPSY WAS NOT PROVIDED. ADDITIONALLY, THE HEALTH PROFESSIONAL REPORTED INJECTING THE PATIENT IN THE CHIN-CHEEKS WITH 3 ML. THE PATIENT WAS PRE-TREATED WITH EMLA CREAM AND RECEIVED A COOL PACK POST-INJECTION. APPROXIMATELY 1 WEEK POST-INJECTION, THE PATIENT EXPERIENCED ¿GRANULOMAS¿ ON THE CHEEKS AND CHIN ¿ JAWLINE (C2, JWS,-JWG). THE PATIENT WAS TREATED WITH 150 UNITS OF HYALASE AND ANOTHER 300 UNITS 3 WEEKS LATER. PER HEALTH PROFESSIONAL, "IMPROVEMENT FINAL RESULTS UNKNOWN."

    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. CLARIFICATION: 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

    HEALTH PROFESSIONAL REPORTED INJECTING A PATIENT IN THE JAWLINE WITH JUVÉDERM® VOLUMA¿. THE PATIENT EXPERIENCED ¿KNOTS/GRANULOMA¿ AT THE INJECTION SITE. BIOPSY WAS NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    300856 JUVEDERM VOLUMA WITH LIDOCAINE IMPLANT, DERMAL, FOR AESTHETIC USE LMH ALLERGAN (PRINGY) VB20A90652

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention EMLA CREAM