BEUDAMED
    FDA Adverse Event Other Summary report: N

    THINPREP IMAGING SYSTEM

    MDR report key: 1941340 · Received December 21, 2010

    Report

    Report Number
    1222780-2010-00214
    Event Type
    Other
    Date Received
    December 21, 2010
    Date of Event
    December 3, 2010
    Report Date
    December 20, 2010
    Manufacturer
    HOLOGIC, INC.
    Product Code
    MKQ
    PMA / PMN Number
    P950039
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    POSSIBLE DIAGNOSTIC CELLS OUTSIDE 22 FIELDS OF VIEW. THE SLIDE WILL NOT BE COMING BACK FOR REVIEW BY HOLOGIC. THE LAB WOULD NOT ALLOW HOLOGIC TO REVIEW THE SLIDE AS PART OF AN UNKNOWN MIX TO CONFIRM THIS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 THINPREP IMAGING SYSTEM AUTOMATED MICROSCOPE FOR CYTOLOGY MKQ HOLOGIC, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other