BEUDAMED
    FDA Adverse Event Other Summary report: N

    THINPREP IMAGING SYSTEM

    MDR report key: 1584179 · Received January 20, 2010

    Report

    Report Number
    1222780-2010-00013
    Event Type
    Other
    Date Received
    January 20, 2010
    Date of Event
    December 23, 2009
    Report Date
    December 23, 2009
    Manufacturer
    HOLOGIC, INC.
    Product Code
    MNM
    PMA / PMN Number
    P020002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    POSSIBLE INJURY - CUSTOMER HAS AN EMPLOYEE WITH CONCERNS REGARDING TOXICITY LEVELS OF RICHARD ALLAN MOUNTING MEDIA, XYLENE AND FORMALIN, ALL REAGENTS USED IN THE PREPARATION OF IMAGER SLIDES. AN OSHA REPORT HAS BEEN FILED BY THE CUSTOMER AS WELL. (B) (4) HAS TRIED REPEATEDLY TO OBTAIN MORE INFO BUT THE CUSTOMER HAS NOT RESPOND TO OUR CALLS FOR FURTHER INFO.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Other