BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK DERMAL FILLER

    MDR report key: 1543038 · Received November 20, 2009

    Report

    Report Number
    2024601-2009-00898
    Event Type
    Injury
    Date Received
    November 20, 2009
    Date of Event
    October 22, 2009
    Report Date
    October 22, 2009
    Manufacturer
    ALLERGAN
    Product Code
    LMH
    PMA / PMN Number
    P800022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    NO INFORMATION

    Narratives

    Description of Event or Problem · 1

    REPORTED EVENT OF "ERYTHEMA AND SWELLING" FROM JOURNAL ARTICLE, "CLINICAL EXPERIENCE WITH FILLER COMPLICATIONS", DERMATOL SURG, 2009; 35:1661 DOI: 10.1111/J.1524-4725.2009.01345.X. IT IS ALLERGAN'S APPROACH TO COMPLIANCE TO RESOLVE ALL DOUBT IN FAVOR OF REPORTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNK DERMAL FILLER LMH ALLERGAN NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Required Intervention