BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JUVEDERM ULTRA XC TSK US

    MDR report key: 3077028 · Received April 22, 2013

    Report

    Report Number
    3005113652-2013-00042
    Event Type
    Injury
    Date Received
    April 22, 2013
    Date of Event
    March 26, 2013
    Report Date
    March 26, 2013
    Manufacturer
    ALLERGAN
    Product Code
    LMH
    PMA / PMN Number
    P050047
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MEDWATCH SENT TO THE FDA ON (B)(4) 2013. DEVICE LABELING: INTENDEDUSE/INDICATIONS: JUVEDERM ULTRA XC INJECTABLE GEL IS INDICATED FOR INJECTION INTO THE MID TO DEEP DERMIS FOR CORRECTION OF MODERATE TO SEVERE FACIAL WRINKLES AND FOLDS (SUCH AS NASOLABIAL FOLDS). WARNINGS: THE PRODUCT MUST NOT BE INJECTED INTO BLOOD VESSELS, INTRODUCTION OF JUVEDERM ULTRA XC INTO THE VASCULATURE MAY OCCLUDE THE VESSELS AND COULD CAUSE INFARCTION OR EMBOLIZATION. ADVERSE EVENTS: THE MOST COMMON INJECTION-SITE RESPONSES FOR JUVEDERM ULTRA XC WERE REDNESS, SWELLING, TENDERNESS, FIRMNESS, LUMP/BUMPS, DISCOLORATION, AND BRUISING. POST-MARKET SURVEILLANCE: ADVERSE EVENTS WITH A FREQUENCY OF 5 OR MORE EVENTS ARE LISTED IN ORDER OF PREVALENCE: ALLERGIC REACTION, BLISTER, INFLAMMATION AT THE INJECTION SITE. PARESTHESIA, INFECTION AT THE INJECTION SITE, BLEEDING AT THE INJECTION SITE, SKIN RASH, MALAISE, HEADACHE, BLANCHING, VISION ABNORMALITIES, ABSCESS AT THE INJECTION SITE, URTICARIA, HERPES SIMPLEX, TELANGIECTASIS, ANGIOEDEMA, FLU-LIKE SYMPTOMS, NAUSEA, VASCULAR EVENT, DYSPNEA, DERMATITIS, GRANULOMA AT THE INJECTION SITE, AND SCAR.

    Description of Event or Problem · 1

    HEALTH PROFESSIONAL REPORTED THAT AFTER INJECTION OF JUVEDERM ULTRA XC IN THE ZYGOMATIC AREA OF THE RIGHT CHEEK, THE PT COMPLAINED OF NUMBNESS AND A "ZING" SENSATION FROM THE RIGHT CHEEK DOWN TO THE CHIN ALONG WITH A HEADACHE. THE PT PROCEEDED TO "PASS OUT" AND AWOKE COMPLAINING OF DECREASED VISION IN THE RIGHT EYE. PT WAS TREATED WITH HYALURONIDASE, ASPIRIN AND NITRO PASTE AND TAKEN TO AN OPHTHALMOLOGIST AFTER REVEALING THAT THEY HAD A HISTORY OF OCULAR MIGRAINES. AT THE END OF THE 40 MINUTE APPOINTMENT WITH THE OPHTHALMOLOGIST, THE PT'S SYMPTOMS WERE "99%" RESOLVED, EXCEPT FOR ONE TINY BLACK SPOT WHICH THE PT VISUALIZED IN THE RIGHT EYE AND THE OPHTHALMOLOGIST NOTED AS A VISUAL FIELD DEFECT. PT WAS REFERRED TO A RETINAL SPECIALIST WHO AFTER EVALUATING THE PT INDICATED THAT THERE MAY BE A SMALL ANEURYSM PRESENT IN A RETINAL ARTERY OF THE RIGHT EYE WITH ACCOMPANIED SWELLING AND A "FUZZY RETINA". PER THE REPORTING HEALTHCARE PROFESSIONAL, AT THIS TIME THE PT'S RETINAL SPECIALIS BELIEVES THE ANEURYSM IS REDUCING IN SIZE AND THE PT HAS NOTED VISION IS NOT IMPACTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    172509 JUVEDERM ULTRA XC TSK US LMH ALLERGAN NA H24LA20039

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Required Intervention TRAZADONE| FLEXERIL| FISH OIL| LIBRAX| XANAX| SUDAFED "AS NEEDED FOR SEASONAL ALLERGIES"| ESTROVEN| EVENING PRIME ROSE