BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MICROAIRE

    MDR report key: 1964021 · Received January 7, 2011

    Report

    Report Number
    2020601-2011-00001
    Event Type
    Injury
    Date Received
    January 7, 2011
    Date of Event
    April 4, 2007
    Report Date
    January 5, 2011
    Manufacturer
    MICROAIRE SURGICAL INSTRUMENTS
    Product Code
    HRX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    RECEIVED REPORT FROM CUSTOMER INDICATING THAT A PT HAD ALLEGEDLY RECEIVED DAMAGE TO THE MEDIAN NERVE DURING A PROCEDURE UTILIZING A MICROAIRE PRODUCT. THE DEVICE WAS NOT RETURNED, AND MINIMAL INFO WAS PROVIDED, HOWEVER, IT WAS DETERMINED THAT THE OCCURRENCE SHOULD BE REPORTED.

    Description of Event or Problem · 1

    RECEIVED REPORT FROM CUSTOMER INDICATING THAT A PT HAD ALLEGEDLY RECEIVED DAMAGE TO THE MEDIAN NERVE DURING A PROCEDURE UTILIZING A MICROAIRE PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MICROAIRE CARPAL TUNNEL RELEASE SYSTEM BLADE HRX MICROAIRE SURGICAL INSTRUMENTS 81010 (NOT AVAILABLE)

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention