BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MICROAIRE

    MDR report key: 678656 · Received February 21, 2006

    Report

    Report Number
    2020601-2006-00004
    Event Type
    Injury
    Date Received
    February 21, 2006
    Date of Event
    January 13, 2006
    Report Date
    February 21, 2006
    Manufacturer
    MICROAIRE SURGICAL INSTRUMENTS
    Product Code
    DWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IN 2006, MICROAIRE RECEIVED A CALL INDICATING THAT A PIN HAD FALLEN LOOSE FROM THE 4800-002 STERNUM SAW GUARD, AND HAD FALLEN INTO THE PT'S CHEST. THE REPORT INDICATED THAT THE PIN WAS RECOVERED, AND THAT THERE WAS NO PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MICROAIRE STERNUM SAW GUARD DWH MICROAIRE SURGICAL INSTRUMENTS 4800-002 *

    Patients

    Seq Age Sex Outcome Treatment
    1 * Required Intervention