BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NASAL SEPTAL BUTTON

    MDR report key: 47468 · Received November 6, 1996

    Report

    Report Number
    1220850-1996-00001
    Event Type
    Malfunction
    Date Received
    November 6, 1996
    Date of Event
    September 19, 1996
    Report Date
    November 1, 1996
    Manufacturer
    HOOD LABORATORIES
    Product Code
    LFB
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    BUTTON WAS IMPLANTED IN 7/95 AND SEPARATED ON 9/19/96. THE DEVICE WAS SEPARATED INTO TWO PIECES, WHICH HAD TO BE REMOVED BY THE PHYSICIAN. CO WAS INFORMED OF THIS EVENT ON 10/9/96.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NASAL SEPTAL BUTTON Implant NASAL SEPTAL BUTTON LFB HOOD LABORATORIES NSB-30 24085

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Required Intervention