BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POLY DIAGNOST UV

    MDR report key: 139299 · Received December 17, 1997

    Report

    Report Number
    1217116-1997-00036
    Event Type
    Injury
    Date Received
    December 17, 1997
    Date of Event
    December 11, 1994
    Report Date
    December 3, 1997
    Manufacturer
    PHILIPS MEDICAL SYSTEMS NORTH AMERICA CO.
    Product Code
    IZI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Description of Event or Problem · 1

    THE PT WAS UNDERGOING A KIDNEY OPERATION AND THE KIDNEY IMAGE AS DISPLAYED ON THE SYSTEM'S IMAGE MONITOR ALLEGEDLY FLIPPED IN ORIENTATION WITHOUT ANY OPERATOR INTERVENTION AND AS A RESULT IT IS ALLEGED THAT THE PT HAD THE WRONG KIDNEY OPERATED UPON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POLY DIAGNOST UV ANGIOGRAPHIC X-RAY SYSTEM IZI PHILIPS MEDICAL SYSTEMS NORTH AMERICA CO. 9804-010-11409 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention