BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JUVEDERM ULTRA PLUS XC TSK US

    MDR report key: 10480086 · Received September 1, 2020

    Report

    Report Number
    3005113652-2020-00490
    Event Type
    Injury
    Date Received
    September 1, 2020
    Date of Event
    July 30, 2020
    Report Date
    October 1, 2020
    Manufacturer
    ALLERGAN (PRINGY)
    Product Code
    LMH
    UDI-DI
    30888628000111
    PMA / PMN Number
    P050047
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL
    Reporter Occupation
    NURSE

    Narratives

    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

    HEALTHCARE PROFESSIONAL (HCP) REPORTS PATIENT INJECTION WITH JUVÉDERM ULTRA PLUS¿ XC IN THE LEFT NLF. WITHIN 10 MINUTES, A "SHADOWING" WAS NOTED IN THE LOWER LEFT NLF AREA AND BEGAN TO TRACK UP THE FOLD AND LEFT SIDE OF NOSE. HCP IMMEDIATELY BEGAN INJECTING HYLENEX TO AREA, TOTAL AMOUNT INJECTED 300 USP. EVENT NOTED AS AN OCCLUSION. PATIENT REMAINED IN OFFICE FOR A TOTAL OF 2 HOURS POST HYLENEX INJECTION, PHOTOS WERE TAKEN AND PATIENT WAS GIVEN INSTRUCTIONS TO APPLY WARM COMPRESSES TO AREA AND TAKE AN ASPIRIN DAILY X 7 DAYS. PATIENT FOLLOW UP OCCURRED DAILY FOR 5 DAYS POST EVENT'S OCCURRENCE. PATIENT SEEN IN OFFICE 2 DAYS AFTER INITIAL TREATMENT AND WAS ASKED TO CONTINUE THE ASPIRIN FOR ANOTHER WEEK, AT THAT TIME THE PATIENT ADMITTED THEY HAD NOT BEEN TAKING THE ASPIRIN. SITE IS HEALING AND PATIENT DOES NOT HAVE ANY "NEW BRUISING" AND DENIES ANY PAIN IN THE AREA. 8 DAYS POST INJECTION, PARTIAL SYMPTOMS RESOLUTION HAS OCCURRED "WITH THE EXCEPTION OF A FEW BROKEN CAPILLARIES."

    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. CLARIFICATION: THE FILLER WAS INJECTED INTO THE PATIENT AND IS NOT ACCESSIBLE FOR RETURN. THE SYRINGE WAS DISCARDED. 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. 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 JUVÉDERM ULTRA PLUS¿ XC IN THE LEFT NLF. WITHIN 10 MINUTES, A "SHADOWING" WAS NOTED IN THE LOWER LEFT NLF AREA AND BEGAN TO TRACK UP THE FOLD AND LEFT SIDE OF NOSE. HCP IMMEDIATELY BEGAN INJECTING HYLENEX TO AREA, TOTAL AMOUNT INJECTED 300 USP. EVENT NOTED AS AN OCCLUSION. PATIENT REMAINED IN OFFICE FOR A TOTAL OF 2 HOURS POST HYLENEX INJECTION, PHOTOS WERE TAKEN AND PATIENT WAS GIVEN INSTRUCTIONS TO APPLY WARM COMPRESSES TO AREA AND TAKE AN ASPIRIN DAILY X 7 DAYS. PATIENT FOLLOW UP OCCURRED DAILY FOR 5 DAYS POST EVENT'S OCCURRENCE. PATIENT SEEN IN OFFICE 2 DAYS AFTER INITIAL TREATMENT AND WAS ASKED TO CONTINUE THE ASPIRIN FOR ANOTHER WEEK, AT THAT TIME THE PATIENT ADMITTED THEY HAD NOT BEEN TAKING THE ASPIRIN. SITE IS HEALING AND PATIENT DOES NOT HAVE ANY "NEW BRUISING" AND DENIES ANY PAIN IN THE AREA. 8 DAYS POST INJECTION, PARTIAL SYMPTOMS RESOLUTION HAS OCCURRED "WITH THE EXCEPTION OF A FEW BROKEN CAPILLARIES."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    944921 JUVEDERM ULTRA PLUS XC TSK US IMPLANT, DERMAL, FOR AESTHETIC USE LMH ALLERGAN (PRINGY) H30LA90514 30888628000111

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Other| R