BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICRO AIRE

    MDR report key: 217108 · Received March 31, 1999

    Report

    Report Number
    MW1016036
    Event Type
    Malfunction
    Date Received
    March 31, 1999
    Date of Event
    March 23, 1999
    Report Date
    March 24, 1999
    Manufacturer
    MICROAIRE SURGICAL INSTRUMENTS, INC.
    Product Code
    GFF
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    BURR BROKE DURING SURGICAL PROCEDURE. ALL THREE PIECES REMOVED WITHOUT INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MICRO AIRE CARBIDE BUR GFF MICROAIRE SURGICAL INSTRUMENTS, INC. CARBIDE BUR, SIDE CUTTING 089835383

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR