BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MICROAIRE

    MDR report key: 769169 · Received October 11, 2006

    Report

    Report Number
    2020601-2006-00012
    Event Type
    Injury
    Date Received
    October 11, 2006
    Date of Event
    June 28, 2005
    Report Date
    October 11, 2006
    Manufacturer
    MICROAIRE SURGICAL INSTRUMENTS
    Product Code
    HRX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON 09/15/2006, A REPORT WAS RECEIVED FROM DR. REGARDING AN ALLEGED PATIENT INJURY WHICH HAD OCCURRED ATOFFICE FACILITY INVOLVING DR. UPON FOLLOW UP WITH (OFFICE MANAGER FOR DR.) IT WAS CONFIRMED THAT THE ALLEGED EVENT OCCURRED IN 2006, IT WAS ALSO CONFIRMED PER ANOTHER DR. THAT THE ALLEGED INJURY WAS NOT THE FAULT OF THE MICROAIRE EQUIPMENT.

    Description of Event or Problem · 1

    ON 09/15/2006, MICROAIRE RECEIVED A REPORT INDICATING THAT A PATIENT INJURY HAD OCCURRED, DURING A PROCEDURE IN WHICH A MICROAIRE CARPAL TUNNEL RELEASE SYSTEM WAS IN USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MICROAIRE CARPAL TUNNEL RELEASE SYSTEM HRX MICROAIRE SURGICAL INSTRUMENTS 81010 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 * Required Intervention