BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MICROAIRE

    MDR report key: 1853304 · Received September 29, 2010

    Report

    Report Number
    2020601-2010-00002
    Event Type
    Injury
    Date Received
    September 29, 2010
    Date of Event
    August 6, 2010
    Report Date
    September 23, 2010
    Manufacturer
    MICROAIRE SURGICAL INSTRUMENTS
    Product Code
    HWE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AND EVALUATION OF THE DEVICE, IT WAS DETERMINED THAT THE DEVICE HAD NOT BEEN CLEANED PROPERLY. IN ADDITION TO COMMUNICATING THE CONCERN TO THE CUSTOMER, PREVENTIVE STEPS WERE TAKEN FOR FUTURE PRODUCTS, TO CLARIFY CLEANING REQUIREMENTS. DUE TO THE EVENT AND REMEDIAL ACTION TAKEN, DECISION WAS MADE TO FILE MEDWATCH REPORT.

    Description of Event or Problem · 1

    RECEIVED REPORT FROM CUSTOMER INDICATING THAT THE INSTRUMENT HAD OVERHEATED, ALLEGEDLY CAUSING A BURN TO THE PATIENT'S LIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MICROAIRE HIGH SPEED DRILL HWE MICROAIRE SURGICAL INSTRUMENTS 2130-000

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR