BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SWANSON REAMER

    MDR report key: 14586 · Received July 8, 1994

    Report

    Report Number
    MW1002759
    Event Type
    Malfunction
    Date Received
    July 8, 1994
    Date of Event
    March 29, 1994
    Report Date
    April 26, 1994
    Manufacturer
    MICRO-AIRE SURGICAL INSTRUMENTS, INC.
    Product Code
    HTW
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    KY, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DRILL BIT BROKE OFF IN THE CARTILAGE OF PT'S NOSE. LEFT IN PLACE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SWANSON REAMER Implant HTW MICRO-AIRE SURGICAL INSTRUMENTS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 53 * Other