BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JUVEDERM ULTRA PLUS XC TSK US

    MDR report key: 4223200 · Received October 27, 2014

    Report

    Report Number
    3005113652-2014-00549
    Event Type
    Injury
    Date Received
    October 27, 2014
    Date of Event
    September 25, 2014
    Report Date
    September 30, 2014
    Manufacturer
    ALLERGAN
    Product Code
    LMH
    PMA / PMN Number
    P050047
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVENT OF NECROSIS, VASCULAR OCCLUSION, ULCERATION, REDNESS AND BRUISING ARE PHYSIOLOGICAL COMPLICATIONS AND ANALYSIS OF THE DEVICE GENERALLY DOES NOT ASSIST ALLERGAN IN DETERMINING A PROBABLE CAUSE FOR THIS EVENT. DEVICE HISTORY RECORD SUMMARY: THE DOCUMENTARY RESEARCH IN THE BATCH FILE SHOWS THAT NO ELEMENT COULD EXPLAIN THESE REACTIONS: ALL THE MANUFACTURING STEPS AND ALL THE PHYSICOCHEMICAL AND MICROBIOLOGICAL RESULTS (ENDOTOXINS, BIOBURDEN) ARE REGISTERED AS CONFORMING TO THE SPECIFICATIONS. THE STERILIZATION CYCLE IS REGISTERED AS CONFORMING.

    Description of Event or Problem · 1

    HEALTHCARE PROFESSIONAL REPORTED AFTER INJECTION IN THE GLABELLA AREA AND A "SCAR IN THE CHIN AREA" WITH 1/3 SYRINGE OF JUVEDERM ULTRA PLUS XC, THE PATIENT DEVELOPED SOME INITIAL BRUISING AND THE HEALTHCARE PROFESSIONAL TOLD THE PATIENT TO ICE THE AREA. ONE DAY AFTER INJECTION, THE PATIENT DEVELOPED "MARKED REDNESS AND ULCERATION" AT THE INJECTION SITE. UPON PRESENTATION TO THE OFFICE 4 DAYS AFTER INJECTION, THE HEALTHCARE PROFESSIONAL OBSERVED A "4-5 MM IN DIAMETER, A SQUARE AREA OF WHAT LOOKS LIKE NECROSIS" IN THE GLABELLA AREA; THERE WERE NO SYMPTOMS OBSERVED AT THE CHIN. THE HEALTHCARE PROFESSIONAL DIAGNOSED THE PATIENT WITH A "VASCULAR OCCLUSION" AND TREATED THE PATIENT WITH HYALURONIDASE, ASPIRIN, TOPICAL ANTIBIOTICS, AND ORAL ANTIBIOTICS. "WITHIN A DAY OR TWO THE PATIENT SHOWED IMPROVEMENT AND HEALING OF THE ULCERATED SKIN. IT HAS NOW BEEN ABOUT 3 WEEKS AND THE PATIENT LOOKS MUCH BETTER WITH JUST MINIMAL REDNESS".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    681078 JUVEDERM ULTRA PLUS XC TSK US LMH ALLERGAN NA H30LA30152

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention