BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JUVEDERM VOLUMA XC/LIDO (VOLUME UNKNOWN)

    MDR report key: 15644483 · Received October 20, 2022

    Report

    Report Number
    3005113652-2022-00689
    Event Type
    Injury
    Date Received
    October 20, 2022
    Date of Event
    January 1, 2022
    Report Date
    November 1, 2022
    Manufacturer
    ALLERGAN (PRINGY)
    Product Code
    LMH
    PMA / PMN Number
    P110033
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). 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. THIS IS A KNOWN POTENTIAL ADVERSE EVENT ADDRESSED IN THE PRODUCT LABELING.

    Description of Event or Problem · 0

    HEALTHCARE PROFESSIONAL REPORTED PATIENT WAS INJECTED IN THE FACE WITH JUVÉDERM® VOLUMA¿ WITH LIDOCAINE AND IN THE DARK CIRCLES WITH JUVÉDERM® VOLBELLA¿ WITH LIDOCAINE. AFTER THE COVID VACCINATION, PATIENT PRESENTED BULGING EYELID, EYE AREA ON ONE SIDE, THAT WAS MANAGED WITH APPLICATION OF HYALURONIDASE AND PREDNISOLONE FOR TWO DAYS AND RADIOFREQUENCY IN THE AREA TO RESOLVE IT. THIS WAS REPEATED 3 MORE TIMES AND SYMPTOMS RESOLVED. SIX MONTHS LATER, PATIENT WAS INJECTED IN THE FACE WITH 3 CC OF JUVÉDERM® VOLUMA¿ WITH LIDOCAINE. ABOUT TWO HOURS AND A HALF LATER, PATIENT REPORTED BRUISING IN LEFT CHEEK AND NASAL AREA AND WAS ASKED TO GO IMMEDIATELY TO THE OFFICE. PATIENT PRESENTED ¿A COMPLICATION [THEY] DEFINED AS THROMBUS IN THE FACE IN THE RIGHT HEMIFACE AND NASAL CONGESTIVE AREA. THAT SAME DAY, PATIENT WAS TREATED WITH SILDENAFIL, PREDNISONE, ASPIRIN, AND PENTOXIFYLLINE. ABOUT TWO HOURS LATER, PATIENT HAD HYALURONIDASE DILUTED IN SALINE SOLUTION AND/OR PLAIN XYLOCAINE INJECTED INTO THE AFFECTED AREA. TRAUMEEL, GRAPHITES HOMACCORD, EMBRYO TOTALIS, CUTIS COMPOSITIUM, COENZYME COMPOSITIUM, LYMPHOMYOSOT, PLACENTA COMPOSITIUM, ENGYSTOL, AND VITAMIN C WERE APPLIED TO THE AFFECTED AREA. PATIENT HAD A SECOND APPLICATION OF HYALURONIDASE DILUTED IN SALINE SOLUTION. THE NEXT DAY, PATIENT WAS TREATED AT HYPERBARIC CHAMBER. THEN, PATIENT WAS TREATED WITH SILDENAFIL, PREDNISONE, ASPIRIN, PENTOXIFYLLINE, AND CLENOZ. ANOTHER HYALURONIDASE DILUTED WITH SIMPLE XYOLICAINE / SALINE SOLUTION WAS INJECTED TO THE AFFECTED AREA THEN "HEEL MEDICATIONS¿ WERE APPLIED TO THE AREA. ANOTHER ROUND OF RADIOFREQUENCY APPLICATION IN THE AREA WAS PERFORMED. HYALURONIDASE DILUTED IN SALINE SOLUTION WAS INJECTED AGAIN THEN PLASMA APPLIED TO AFFECTED AREA. PATIENT WAS THEN GIVEN SILDENAFIL, ASPIRIN, PENTOXIFYLLINE, AND CLENOX. PATIENT CONTINUED WITH HYPERBARIC CHAMBER (FOR FIVE DAYS), APPLICATION OF HEEL PRODUCTS IN THE AREA (FOR 8 DAYS), PLASMA APPLICATION (8 DAYS) AND START ANTIBIOTIC TREATMENT WITH CEFREADOXIL FOR ONE WEEK. THE EVENT IS ONGOING. THIS IS THE SAME EVENT AND THE SAME PATIENT REPORTED UNDER MDR ID# 3005113652-2022-00675 (ALLERGAN COMPLAINT #(B)(4) MDR ID# 3005113652-2022-00690 (ALLERGAN COMPLAINT #(B)(4). THIS MDR IS BEING SUBMITTED FOR THE FIRST SUSPECT PRODUCT, JUVÉDERM® VOLUMA¿ WITH LIDOCAINE.

    Description of Event or Problem · 0

    ADDITIONALLY, PATIENT WAS INJECTED WITH 3 CC INTO ZYGOMATIC, PREJOLWS, MOUTH AND TEMPORAL ANGLES. EVENT RESOLVED APPROXIMATELY SIX MONTHS AFTER DATE OF ONSET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2454448 JUVEDERM VOLUMA XC/LIDO (VOLUME UNKNOWN) IMPLANT, DERMAL, FOR AESTHETIC USE LMH ALLERGAN (PRINGY) NI

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Female Required Intervention| O