BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JUVEDERM ULTRA PLUS XC TSK US

    MDR report key: 8257514 · Received January 17, 2019

    Report

    Report Number
    3005113652-2019-00054
    Event Type
    Injury
    Date Received
    January 17, 2019
    Date of Event
    December 20, 2018
    Report Date
    February 22, 2019
    Manufacturer
    ALLERGAN (PRINGY)
    Product Code
    LMH
    PMA / PMN Number
    P050047
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THE EVENTS OF "PAIN IN RIGHT PROXIMAL NLF, PAIN IN RIGHT NOSE, BLOTCHY RED AREAS ON SKIN SURFACE WITH GREY & WHITE AREAS & PURPLE AREAS" ARE PHYSIOLOGICAL COMPLICATIONS AND ANALYSIS OF THE DEVICE GENERALLY DOES NOT ASSIST ALLERGAN IN DETERMINING A PROBABLE CAUSE FOR THIS EVENT. A REVIEW OF THE DEVICE HISTORY RECORD HAS BEEN INITIATED. IF ANY DEVIATIONS OR NON-CONFORMANCES ARE FOUND, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED.

    Description of Event or Problem · 0

    HEALTHCARE PROFESSIONAL REPORTED THE DAY AFTER INJECTION WITH 1 SYRINGE OF JUVÉDERM® ULTRA PLUS XC IN THE NLF¿S, ORAL COMMISSURES, AND MARIONETTE LINES THE PATIENT DEVELOPED VASCULAR OCCLUSION. THE PATIENT HAD PAIN IN RIGHT PROXIMAL NLF, PAIN IN RIGHT NOSE. BLOTCHY RED AREAS ON SKIN SURFACE WITH GREY & WHITE AREAS & PURPLE AREAS. THE DAY SYMPTOMS BEGAN THE PATIENT WAS TREATED WITH VITRASE INJECTED IN RIGHT PROXIMAL NLF, STARTED MOTRIN 400, WARM SOAKS, AND MASSAGE. THE SAME TREATMENT WAS PROVIDED 2 DAYS LATER AND OVER THE NEXT WEEK PLUS THE PATIENT WAS TREATED WITH: HYPERBARIC OXYGEN THERAPY, ASPIRIN, STEROIDS, & ANTIBIOTICS. THE PATIENT HAS HAD PREVIOUS DERMAL FILLERS, BUT NO OTHER NOTABLE MEDICAL CONDITIONS. SYMPTOMS ARE ONGOING, BUT ALMOST COMPLETELY RESOLVED.

    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 OF "VASCULAR OCCLUSION" 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 · 1

    HEALTHCARE PROFESSIONAL REPORTED AFTER INJECTION WITH AN UNKNOWN JUVÉDERM®, THE PATIENT WAS TREATED WITH VITRASE FOR A VASCULAR OCCLUSION. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    50256 JUVEDERM ULTRA PLUS XC TSK US IMPLANT, DERMAL, FOR AESTHETIC USE LMH ALLERGAN (PRINGY) H30LA80309

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention