BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MICROAIRE

    MDR report key: 661432 · Received January 6, 2006

    Report

    Report Number
    2020601-2006-00002
    Event Type
    Injury
    Date Received
    January 6, 2006
    Date of Event
    December 8, 2005
    Report Date
    January 6, 2006
    Manufacturer
    MICROAIRE SURGICAL INSTRUMENTS, LLC
    Product Code
    HTW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    A MICROAIRE REP HAD RECEIVED A REPORT. THE REPORT INDICATED THAT A TWIST DRILL HAD ALLEGEDLY BROKEN OFF INSIDE A PATIENT AND REQUIRED 1/2 HOUR TO REMOVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MICROAIRE 2.0MM ECT TWIST DRILL HTW MICROAIRE SURGICAL INSTRUMENTS, LLC 8054-020NS UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 * Required Intervention