BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUB MUCOSAL UPP ELECTRODE

    MDR report key: 506279 · Received January 14, 2004

    Report

    Report Number
    2428235-2004-00001
    Event Type
    Injury
    Date Received
    January 14, 2004
    Date of Event
    August 1, 2003
    Report Date
    January 6, 2004
    Manufacturer
    ELLMAN INTL., INC.
    Product Code
    JOS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    VELOPHARYGEAL INSUFFICIENCY - MAY NEED PHARYNGEAL FLAP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SUB MUCOSAL UPP ELECTRODE STANDARD ELECTRODE JOS ELLMAN INTL., INC. NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other