BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    H9101-OVAL BURR

    MDR report key: 1902921 · Received November 12, 2010

    Report

    Report Number
    MW5018209
    Event Type
    Malfunction
    Date Received
    November 12, 2010
    Date of Event
    October 20, 2010
    Report Date
    November 12, 2010
    Manufacturer
    ASCENT HEALTHCARE SOLUTIONS
    Product Code
    HRX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CT, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    WHEN A 4.0MM OVAL BURR WAS USED ON THE ACROMIAN, METAL FLAKES WERE OBSERVED ON THE SURGICAL MONITOR INSIDE THE SHOULDER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 H9101-OVAL BURR NONE HRX ASCENT HEALTHCARE SOLUTIONS H9101 1058036

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Other