BEUDAMED
    FDA Adverse Event Other Summary report: N

    INPREP IMAGING SYSTEM

    MDR report key: 3289959 · Received August 7, 2013

    Report

    Report Number
    1222780-2013-00146
    Event Type
    Other
    Date Received
    August 7, 2013
    Date of Event
    July 22, 2013
    Report Date
    July 23, 2013
    Manufacturer
    HOLOGIC INC
    Product Code
    MNM
    PMA / PMN Number
    P020002
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    REPORT OF POSSIBLE DIAGNOSTIC CELLS OUTSIDE FIELD OF VIEW. SLIDE NOT AVAILABLE FOR REVIEW BY HOLOGIC'S CYTOTECHNOLOGIST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    371488 INPREP IMAGING SYSTEM AUTOMATED MICROSCOPE FOR CYTOLOGY MNM HOLOGIC INC

    Patients

    Seq Age Sex Outcome Treatment
    1 Other