BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGENY PREVA

    MDR report key: 1812478 · Received August 13, 2010

    Report

    Report Number
    1423380-2010-00028
    Event Type
    Malfunction
    Date Received
    August 13, 2010
    Date of Event
    July 15, 2010
    Report Date
    August 6, 2010
    Manufacturer
    MIDMARK CORP
    Product Code
    MUH
    PMA / PMN Number
    K043092
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    DENTIST

    Narratives

    Description of Event or Problem · 1

    A FIELD TECHNICIAN OF A DEALER REPORTED THAT THE MECHANICAL STRUCTURE OF A PREVA INTRA-ORAL X-RAY UNIT SEPARATED FROM THE WALL AT DR. (B)(6) DENTAL OFFICE. THE DOCTOR MENTIONED THAT THE MACHINE STRUCK AN EMPLOYEE, BUT HE DECLINED TO DISCLOSE THE EMPLOYEE'S NAME AND WHETHER THE EMPLOYEE WAS INJURED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROGENY PREVA MUH MIDMARK CORP PREVA

    Patients

    Seq Age Sex Outcome Treatment
    1