BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HYALURONIC ACID, HYLURONIC ACID

    MDR report key: 3902245 · Received June 25, 2014

    Report

    Report Number
    2032896-2014-00500
    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 Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS CASE IS ALSO LINKED TO FOUR OTHER CASES: (B)(4). CHEN Y, WANG W, LI J, YU YI, LI L, LU N. FUNDUS ARTERY OCCLUSION CAUSED BY COSMETIC FACIAL INJECTIONS. CHIN MED J (ENGL). 2014; 127 (8): 1434-7. FOLLOW UP LETTER (1) SENT ON 04/06/2014. FOLLOW UP LETTER (2) SENT ON 19/06/2014.

    Description of Event or Problem · 1

    THIS SPONTANEOUS CASE WAS RECEIVED ON (B)(6) 2014, VIA A LITERATURE ARTICLE AND CONCERNED A (B)(6) YEAR OLD FEMALE PATIENT. THE PATIENT 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 NONARTERITIC RETINAL ARTERY OCCLUSION NEWLY DIAGNOSED BY FUNDUS FLUORESCENT 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 PATIENT RECEIVED HYLURONIC ACID COSMETICF FACIAL INJECTION IN THE NOSE AREA NEAR THE LEFT EYE. THE BATCH NUMBER USED WAS NOT REPORTED. ON AN UNSPECIFIED DATE. AFTER THE HYLURONIC ACID INJECTION, THE PATIENT EXPERIENCED ANTERIOR ISCHEMIC OPTIC NEUROPATHY. THE PATIENT FELT DECREASED VISION IMMEDIATELY AFTER THE INJECTION. AND SHE ALSO FELT A HEADACHE. THE FUNDUS SHOWED TEMPORAL OPTIC DISC EDEMA. THE INITIAL BCVA WAS 0.05 AND THE FINAL BCVA WAS 0.02. THE OUTCOME OF THE EVENT WAS UNKNOWN. THE REPORTER DID NOT PROVIDE A CAUSALITY ASSESSMENT. ALL OF THE INJECTION SITES IN THE FACE MIGHT CAUSE ARTERY OCCLUSION; THEREFORE, PATIENTS SHOULD BE INFORMED ABOUT THE RISK OF IRREVERSIBLE BLINDNESS FROM FUNDUS ARTERY OCCLUSION, AND THE INJECTIONS SHOULD BE PERFORMED CAREFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    370624 HYALURONIC ACID, HYLURONIC ACID INJECTABLE DERMAL FILLER LMH

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Other