BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGENY PREVA

    MDR report key: 3083089 · Received April 29, 2013

    Report

    Report Number
    1423380-2013-00002
    Event Type
    Malfunction
    Date Received
    April 29, 2013
    Date of Event
    April 2, 2013
    Report Date
    April 26, 2013
    Manufacturer
    MIDMARK CORPORATION
    Product Code
    EHD
    PMA / PMN Number
    K043092
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    DENTAL ASSISTANT

    Narratives

    Description of Event or Problem · 1

    THE MECHANICAL STRUCTURE OF A PREVA UNIT, SERIAL NUMBER (B)(4), SEPARATED FROM THE WALL. A PROGENY SALES REPRESENTATIVE SPOKE TO THE DENTAL OFFICE AND CONFIRMED THERE WAS NO INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    185331 PROGENY PREVA UNIT, X-RAY, EXTRAORAL WITH TIMER EHD MIDMARK CORPORATION PREVA

    Patients

    Seq Age Sex Outcome Treatment
    1