BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JUVEDERM ULTRA PLUS/30HV (VOLUME UNKNOWN)

    MDR report key: 3780715 · Received April 21, 2014

    Report

    Report Number
    3005113652-2014-00134
    Event Type
    Injury
    Date Received
    April 21, 2014
    Date of Event
    August 10, 2013
    Report Date
    March 13, 2014
    Manufacturer
    ALLERGAN
    Product Code
    LMH
    PMA / PMN Number
    P050047
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MEDWATCH SENT TO FDA ON: 04/21/2014. FURTHER INFO FROM THE REPORTER REGARDING EVENT, PRODUCT, OR PT DETAILS HAS BEEN REQUESTED. AUTHORS HAVE INDICATED THAT NO ADDITIONAL INFO IS AVAILABLE. THE EVENT OF "OPTHALMIC ARTERY OCCLUSION", VISION LOSS, NO LIGHT PERCEPTION, AND NECROSIS ARE PHYSIOLOGICAL COMPLICATIONS AND ANALYSIS OF THE DEVICE GENERALLY DOES NOT ASSIST ALLERGAN IN DETERMINING A PROBABLE CAUSE FOR THIS EVENT.

    Description of Event or Problem · 1

    HEALTHCARE PROFESSIONAL REPORTED IMMEDIATELY AFTER INJECTION WITH JUVEDERM ULTRA PLUS IN THE GLABELLA AND NASAL DORSUM PT EXPERIENCED RETINAL ARTERY OCCLUSION WITH SUBSEQUENT VISION LOSS AND "NO LIGHT PERCEPTION" IN THE "UNILATERAL EYE" AS WELL AS NECROSIS AT THE INJECTION SITES. PT WAS TREATED WITH "INTRA-ARTERIAL THROMBOLYSIS WITH HYALURONIDASE". THE "SKIN LESION" RESULTING FROM NECROSIS AT THE INJECTION SITES IMPROVED 2 MONTHS" AFTER INJECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    241432 JUVEDERM ULTRA PLUS/30HV (VOLUME UNKNOWN) LMH ALLERGAN NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR Required Intervention