BEUDAMED
    FDA Adverse Event Other Summary report: N

    SUREPATH PRECOAT SLIDE

    MDR report key: 1011970 · Received March 7, 2008

    Report

    Report Number
    1062336-2008-00003
    Event Type
    Other
    Date Received
    March 7, 2008
    Date of Event
    February 21, 2008
    Report Date
    March 7, 2008
    Manufacturer
    TRIPATH IMAGING, INC.
    Product Code
    OHL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE LAB WAS NOT ABLE TO RETURN THE SLIDE FOR EVALUATION OR PROVIDE A LOT NUMBER. THE DEVICE IN QUESTION IS A STANDARD GLASS MICROSCOPE SLIDE COMMONLY USED FOR CERVICAL CYTOLOGY. THERE IS A RISK OF BREAKAGE WITH ANY GLASS ITEM. A CAPA HAS BEEN INITIATED TO INVESTIGATE THE EVENT DETERMINE IF ANY ACTION IS POSSIBLE TO PREVENT RECURRENCE.

    Description of Event or Problem · 1

    CUSTOMER CALLED TO COMPLAIN THAT THEY HAVE HAD A PROBLEM WITH SLIDES HAVING SHARDS OF GLASS IN THE PACKAGING. EMPLOYEES HAVE BEEN CUTTING THEIR HANDS ON THE SLIDES AND RECENTLY AN EMPLOYEE HAD A PIECE GO IN HER EYE WHEN THE SLIDE WAS PLACED UNDER THE CLIP ON THE MICROSCOPE STAGE. THE CYTOTECHNOLOGIST FELT SOMETHING SHARP IN HER EYE JUST AS SHE PLACED THE SLIDE UNDER THE CLIP. THE EMPLOYEE WENT TO THE DOCTOR AND HAD SCRATCHED THE EYE. ACCORDING TO THE DOCTOR, CYTOTECHNOLOGISTS DO NOT BLINK THEIR EYES AS MUCH, THUS CAUSING THE EYE TO BE OPEN AND DRY. THERE WAS NO DAMAGE TO THE EYE AND SHE WAS TREATED WITH EYE DROPS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SUREPATH PRECOAT SLIDE SUREPATH LIQUID-BASED PAP TEST OHL TRIPATH IMAGING, INC. NA NOT KNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other