BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JUVEDERM (VOLUME/CONCENTRATION UNK)

    MDR report key: 3940424 · Received June 18, 2014

    Report

    Report Number
    3005113652-2014-00279
    Event Type
    Injury
    Date Received
    June 18, 2014
    Date of Event
    June 7, 2013
    Report Date
    June 7, 2013
    Manufacturer
    ALLERGAN
    Product Code
    LMH
    PMA / PMN Number
    P050047
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    FURTHER INFO FROM THE REPORTED REGARDING EVENT, PRODUCT, OR PT DETAILS HAS BEEN REQUESTED. NO ADDITIONAL INFO IS AVAILABLE AT THIS TIME. THE EVENTS OF "BLANCHING" AND "VASCULAR EVENT" ARE PHYSIOLOGICAL COMPLICATIONS AND ANALYSIS OF THE DEVICE DOES NOT ASSIST ALLERGAN IN DETERMINING A PROBABLE CAUSE FOR THESE EVENTS.

    Description of Event or Problem · 1

    PT'S SPOUSE REPORTED AFTER INJECTION OF UNSPECIFIED JUVEDERM IN THE LIPS, THE PT EXPERIENCED AN "ARTERIAL OCCLUSION"; FOLLOW UP WITH PT CONFIRMED THE EVENT. ADDITIONAL INFO PROVIDED BY THE HEALTHCARE PROFESSIONAL NOTED THE PT "DEVELOPED BLANCHING FROM NLF TO NOSE" WHICH THEY BELIEVED WAS AN "ARTERIAL/VASCULAR OCCLUSION". PT SYMPTOMS RESOLVED QUICKLY WITH "TREATMENT"; THE PT HAS SINCE BEEN "RETREATED" IN THE AREA "WITHOUT ANY DIFFICULTIES".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    357766 JUVEDERM (VOLUME/CONCENTRATION UNK) LMH ALLERGAN NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Required Intervention