BEUDAMED
    FDA Adverse Event Other Summary report: N

    BUCKY DIAGNOST TH

    MDR report key: 1262763 · Received November 5, 2008

    Report

    Report Number
    1217116-2008-00079
    Event Type
    Other
    Date Received
    November 5, 2008
    Date of Event
    October 6, 2008
    Report Date
    October 6, 2008
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    KPR
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THIS REPORT IS BEING FILED UPON NOTIFICATION FROM OUR X-RAY MFR, TO SUBMIT THIS EVENT THAT OCCURRED IN ANOTHER COUNTRY. PROBLEM: THE AUTOMATIC COLLIMATOR (NICOL V3) OF THIS X-RAY SYSTEM FELL OFF THE SYSTEM DURING EXAMINATION OF A PT. THE PT'S FACE WAS HIT BY THE COLLIMATOR; AND SUFFERED A LACERATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BUCKY DIAGNOST TH KPR (STATIONARY X-RAY SYSTEM) KPR PHILIPS MEDICAL SYSTEMS 704035 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other