BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HYALURONIC ACID, HYALURONIC ACID

    MDR report key: 3902308 · Received June 25, 2014

    Report

    Report Number
    2032896-2014-00502
    Event Type
    Injury
    Date Received
    June 25, 2014
    Report Date
    May 23, 2014
    Product Code
    LMH
    PMA / PMN Number
    P020023
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVENT ARTERIAL OCCLUSIVE DISEASE IS ASSESSED AS SERIOUS AND POSSIBLY RELATED.

    Description of Event or Problem · 1

    THIS SPONTANEOUS CASE WAS RECEIVED ON (B)(4) 2014 VIA A LITERATURE ARTICLE AND CONCERNED A (B)(6) FEMALE PT. THE PT WAS HEALTHY WITHOUT HYPERTENSION, DIABETES, AND OTHER UNDERLYING DISEASES. HER MEDICAL HISTORY WAS RELEVANT FOR COSMETIC FACIAL FILLER INJECTION IMMEDIATELY BEFORE FUNDUS ARTERY OCCLUSION AND NON-ARTERITIC RETINAL ARTERY OCCLUSION NEWLY DIAGNOSED BY FUNDUS FLUORESCEIN ANGIOGRAPHY. SHE SHOWED NO HISTORY OF INTRAOCULAR SURGERY OR RETINAL ARTERY OCCLUSION BEFORE SYMPTOM DEVELOPMENT. CONCOMITANT MEDICATIONS WERE NOT REPORTED. ON AN UNSPECIFIED DATE, THE PT RECEIVED HYALURONIC ACID COSMETIC FACIAL INJECTION (2.1 ML) IN THE FRONTAL AREA NEAR THE LEFT EYE. THE SIZE OF THE NEEDLE USED FOR THE INJECTION WAS REPORTED TO BE 27 GAUGE AND 30 GAUGE. THE BATCH NUMBER USED WAS NOT REPORTED. ON AN UNSPECIFIED DATE, AFTER THE HYALURONIC ACID INJECTION, THE PT EXPERIENCED INCOMPLETE OPHTHALMIC ARTERY OCCLUSION. THE INITIAL BCVA WAS HM AND THE FINAL BCVA WAS 0.02. CHERRY-RED SPOT WAS SEEN WITH PARTIAL CHOROID FILLING OF FLUORESCEIN IN THE EARLY STAGE. IT SHOWED DELAYED FILLING OF RETINAL AND CHOROIDAL CIRCULATION AT TWO WEEKS FOLLOW-UP. THE OUTCOME OF THE EVENT WAS UNK. THE REPORTER DID NOT PROVIDE A CAUSALITY ASSESSMENT. AUTHORS COMMENTS: ALL OF THE INJECTION SITES IN THE FACE MIGHT CAUSE ARTERY OCCLUSION. THEREFORE, PTS SHOULD BE INFORMED ABOUT THE RISK OF IRREVERSIBLE BLINDNESS FROM FUNDUS ARTERY OCCLUSION, AND THE INJECTIONS SHOULD BE PERFORMED CAREFULLY. CHEN Y, WANG W, LI J, LI L, LU N. FUNDUS ARTERY OCCLUSION CAUSED BY COSMETIC FACIAL INJECTIONS. CHIN MED J (ENGL). 2014; 127 (8): 1434-7. THIS CASE IS ALSO LINKED TO OTHER FOUR CASES: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    370598 HYALURONIC ACID, HYALURONIC ACID INJECTABLE DERMAL FILLER LMH

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR Other