BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BUCKYDIAGNOST

    MDR report key: 2010908 · Received March 4, 2011

    Report

    Report Number
    3003768251-2011-00022
    Event Type
    Injury
    Date Received
    March 4, 2011
    Date of Event
    February 23, 2011
    Report Date
    February 23, 2011
    Manufacturer
    PHILIPS MEDICAL SYSTEMS DMC GMBH
    Product Code
    KPR
    PMA / PMN Number
    K945278
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE INVESTIGATION IS CURRENTLY ONGOING AND CONCLUSIONS WILL BE SENT IN A F/U REPORT BEFORE (B)(4) 2011.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT AN X-RAY ASSISTANT BANGED HER HEAD AT THE EDGES OF THE DOSE MEASURING RAIL. THE HEAD INJURY WAS SEWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BUCKYDIAGNOST KPR PHILIPS MEDICAL SYSTEMS DMC GMBH 704031

    Patients

    Seq Age Sex Outcome Treatment
    1 Other