BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JUVEDERM ULTRA XC TSK US

    MDR report key: 16137497 · Received January 11, 2023

    Report

    Report Number
    3005113652-2023-00007
    Event Type
    Injury
    Date Received
    January 11, 2023
    Date of Event
    December 19, 2022
    Report Date
    January 11, 2023
    Manufacturer
    ALLERGAN (PRINGY)
    Product Code
    LMH
    UDI-DI
    30888628000081
    PMA / PMN Number
    P050047
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    117

    Narratives

    Additional Manufacturer Narrative · 0

    SUSPECT PRODUCT: LOT NUMBER 963/2. (B)(4). 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. 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 INJECTING A PATIENT IN THE LIPS WITH .3 CC OF JUVÉDERM® ULTRA XC. THE PATIENT EXPERIENCED ¿VASCULAR OCCLUSION¿ AT THE INJECTION SITE THAT DAY. THREE DAYS LATER, THE PATIENT WAS TREATED AT ANOTHER OFFICE WITH HYLENEX, ANTIBIOTICS, PREDNISONE, AND VALTREX. AN ULTRASOUND WAS PERFORMED BY A DIFFERENT HEALTHCARE PROFESSIONAL, AND THE RESULTS NOTED AS ¿DARK AREA AROUND LATERAL ASPECT OF SLI WHICH APPEARED COMPRESSED BY HYALURONIC ACID. INFERIOR ASPECT OF COLUMELLAR ARTERY THAT MEETS AT TOP OF PATIENT¿S GK POINT ALSO DARK.¿ ANOTHER ULTRASOUND WAS PERFORMED THE NEXT DAY WITH THE RESULTS NOTED AS ¿ULTRASOUND: MEDIAL PORTION OF UPPER LIP, AT THE GK POINT AND THE PHILTRAL COLUMN SLUGGISH. CAP REFILL. COLOR DOPLER SHOWED PERFUSION OF VESSELS ¿ SEPTAL BRANCH AND COLUMELLAR BRANCH.¿ THE EVENT RESOLVED 3 DAYS LATER, BUT AFTER 5 DAYS, THE PATIENT WAS STARTED ON CUTAGENIX TOPICAL AND A TOTAL OF 1800 UNITS OF HYLENEX AND 1500 OF HYALURONIDASE. THE EVENT IMPROVED.

    Description of Event or Problem · 0

    HEALTHCARE PROFESSIONAL REPORTED INJECTING A PATIENT IN THE LIPS WITH .3 CC OF JUVÉDERM® ULTRA XC. THE PATIENT EXPERIENCED ¿VASCULAR OCCLUSION¿ AT THE INJECTION SITE THAT DAY. THREE DAYS LATER, THE PATIENT WAS TREATED AT ANOTHER OFFICE WITH HYLENEX, ANTIBIOTICS, PREDNISONE, AND VALTREX. AN ULTRASOUND WAS PERFORMED BY A DIFFERENT HEALTHCARE PROFESSIONAL, AND THE RESULTS NOTED AS ¿DARK AREA AROUND LATERAL ASPECT OF SLI WHICH APPEARED COMPRESSED BY HYALURONIC ACID. INFERIOR ASPECT OF COLUMELLAR ARTERY THAT MEETS AT TOP OF PATIENT¿S GK POINT ALSO DARK.¿ ANOTHER ULTRASOUND WAS PERFORMED THE NEXT DAY WITH THE RESULTS NOTED AS ¿ULTRASOUND: MEDIAL PORTION OF UPPER LIP, AT THE GK POINT AND THE PHILTRAL COLUMN SLUGGISH. CAP REFILL. COLOR DOPLER SHOWED PERFUSION OF VESSELS ¿ SEPTAL BRANCH AND COLUMELLAR BRANCH.¿ THE EVENT RESOLVED 3 DAYS LATER, BUT AFTER 5 DAYS, THE PATIENT WAS STARTED ON CUTAGENIX TOPICAL AND A TOTAL OF 1800 UNITS OF HYLENEX AND 1500 OF HYALURONIDASE. THE EVENT IMPROVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1420212 JUVEDERM ULTRA XC TSK US IMPLANT, DERMAL, FOR AESTHETIC USE LMH ALLERGAN (PRINGY) 1000510633 30888628000081

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Female Required Intervention| O