BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JUVEDERM VOLUMA WITH LIDOCAINE 1ML

    MDR report key: 10162595 · Received June 17, 2020

    Report

    Report Number
    3005113652-2020-00304
    Event Type
    Injury
    Date Received
    June 17, 2020
    Date of Event
    February 15, 2020
    Report Date
    June 17, 2020
    Manufacturer
    ALLERGAN (PRINGY)
    Product Code
    LMH
    PMA / PMN Number
    P110033
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    CLARIFICATION TO H6: THE FILLER WAS INJECTED INTO THE PATIENT AND IS NOT ACCESSIBLE FOR RETURN. THE SYRINGE WAS DISCARDED. CORRECTED DATA: H.6

    Description of Event or Problem · 0

    HEALTHCARE PROFESSIONAL (HCP) REPORTED TO HAVE INJECTED THE PATIENT IN CK1 4 3, CK5, C1 2 6, JW 4 5 32, AND NLF WITH 2 SYRINGES OF JUVÉDERM¿ VOLUMA¿ WITH LIDOCAINE. OVER 3 MONTHS LATER THE PATIENT WAS INJECTED IN CK3, TT 123, NLF 123, AND MLF 123 WITH 2 SYRINGES OF JUVÉDERM® VOLIFT¿ WITH LIDOCAINE. THE PATIENT WAS TAKING SYNTHROID® REPLACEMENT AND HCT ¿ FN -BP CONCOMITANTLY. ALMOST 5 MONTHS LATER THE PATIENT PRESENTED RED TENDER NODULES IN THE RIGHT AND LEFT PREAURICULAR AREA. THE CHEEKS FELT VERY TENDER. NO FEVER. ¿VIRAL ILLNESS 2 WEEKS FOLLOWING¿. 11 DAYS LATER THE PATIENT WAS TREATED WITH DOXYCYCLINE. ALMOST 3 WEEKS LATER THE PATIENT WAS SWITCHED TO BINCM + CIPRO PO BID X 2 WEEKS. ON THE FOLLOWING DAY AN I & D OF NODULES WAS PERFORMED, WHICH SHOWED ¿STAPH EPIDERMIDIS¿. 5 DAYS LATER A C & S TEST OF PUS WAS PERFORMED SHOWING ¿¿@ SKIN NUCLEUS¿. THE TREATMENT WAS REPORTED AS NECESSARY TO PREVENT PERMANENT DAMAGE. THE HCP ADDED THAT THE EVENT LED TO PERMANENT DAMAGE AND EXPLAINED ¿ATROPHIC SCAR L CHEEK 2 1/ I & D 2: TELANGIECTASIA ¿ R PREAURICULAR AREA.¿ THE EVENT RESOLVED ABOUT A MONTH AND A WEEK LATER. THIS IS THE SAME EVENT AND THE SAME PATIENT REPORTED UNDER MDR ID # 3005113652-2020-00303 (ALLERGAN COMPLAINT # 3005113652-2020-00303). THIS IS THE FIRST MDR SUBMITTED FOR THE FIRST SUSPECT PRODUCT, JUVÉDERM¿ VOLUMA¿ WITH LIDOCAINE.

    Additional Manufacturer Narrative · 1

    (B)(6). A REVIEW OF THE DEVICE HISTORY RECORD HAS BEEN COMPLETED. NO DEVIATIONS OR NON-CONFORMANCES NOTED. THE REPORTED EVENTS ARE PHYSIOLOGICAL COMPLICATIONS AND ANALYSIS OF THE DEVICE GENERALLY DOES NOT ASSIST ALLERGAN IN DETERMINING A PROBABLE CAUSE FOR THESE EVENT. FURTHER INFORMATION FROM THE REPORTER REGARDING EVENT, PRODUCT, OR PATIENT DETAILS HAS BEEN REQUESTED. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. THESE ARE KNOWN POTENTIAL ADVERSE EVENT ADDRESSED IN THE PRODUCT LABELING.

    Description of Event or Problem · 1

    HEALTHCARE PROFESSIONAL (HCP) REPORTED TO HAVE INJECTED THE PATIENT IN CK1 4 3, CK5, C1 2 6, JW 4 5 32, AND NLF WITH 2 SYRINGES OF JUVÉDERM¿ VOLUMA¿ WITH LIDOCAINE. OVER 3 MONTHS LATER THE PATIENT WAS INJECTED IN CK3, TT 123, NLF 123, AND MLF 123 WITH 2 SYRINGES OF JUVÉDERM® VOLIFT¿ WITH LIDOCAINE. THE PATIENT WAS TAKING SYNTHROID® REPLACEMENT AND HCT ¿ FN -BP CONCOMITANTLY. ALMOST 5 MONTHS LATER THE PATIENT PRESENTED RED TENDER NODULES IN THE RIGHT AND LEFT PREAURICULAR AREA. THE CHEEKS FELT VERY TENDER. NO FEVER. ¿VIRAL ILLNESS 2 WEEKS FOLLOWING¿. 11 DAYS LATER THE PATIENT WAS TREATED WITH DOXYCYCLINE. ALMOST 3 WEEKS LATER THE PATIENT WAS SWITCHED TO BINCM + CIPRO PO BID X 2 WEEKS. ON THE FOLLOWING DAY AN I & D OF NODULES WAS PERFORMED, WHICH SHOWED ¿STAPH EPIDERMIDIS¿. 5 DAYS LATER A C & S TEST OF PUS WAS PERFORMED SHOWING ¿¿@ SKIN NUCLEUS¿. THE TREATMENT WAS REPORTED AS NECESSARY TO PREVENT PERMANENT DAMAGE. THE HCP ADDED THAT THE EVENT LED TO PERMANENT DAMAGE AND EXPLAINED ¿ATROPHIC SCAR L CHEEK 2 1/ I & D 2: TELANGIECTASIA ¿ R PREAURICULAR AREA.¿ THE EVENT RESOLVED ABOUT A MONTH AND A WEEK LATER. THIS IS THE SAME EVENT AND THE SAME PATIENT REPORTED UNDER MDR ID # 3005113652-2020-00303 (ALLERGAN COMPLAINT # (B)(4)). THIS IS THE FIRST MDR SUBMITTED FOR THE FIRST SUSPECT PRODUCT, JUVÉDERM¿ VOLUMA¿ WITH LIDOCAINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    628183 JUVEDERM VOLUMA WITH LIDOCAINE 1ML IMPLANT, DERMAL, FOR AESTHETIC USE LMH ALLERGAN (PRINGY) VB20A80501

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention| S SYNTHROID® REPLACEMENT AND HCT ¿ FN -BP.| SYNTHROID® REPLACEMENT AND HCT ¿ FN -BP.