BEUDAMED
    FDA Adverse Event Other Summary report: N

    SUREPATH PRECOAT SLIDE

    MDR report key: 1565272 · Received December 21, 2009

    Report

    Report Number
    1062336-2009-00004
    Event Type
    Other
    Date Received
    December 21, 2009
    Date of Event
    November 26, 2009
    Report Date
    December 21, 2009
    Manufacturer
    TRIPATH IMAGING, INC.
    Product Code
    MKQ
    PMA / PMN Number
    P970018
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE LAB CANNOT RETURN THE EXACT SLIDE FOR EVALUATION. A BOX FROM THAT SAME LOT NUMBER IS BEING RETURNED FOR EXAMINATION. TO DATE, IT IS NOT RECEIVED BY MFR. 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. THERE HAVE BEEN NO CHANGES TO GLASS MATERIAL, PACKAGING OR SHIPPING CONDITIONS. NO FURTHER CORRECTIVE ACTION IS PLANNED.

    Description of Event or Problem · 1

    CUSTOMER (CYTOTECHNOLOGIST) REPORTED THAT SUREPATH PRECOAT SLIDE, BROKE WHEN PLACING SLIDE ONTO MICROSCOPE STAGE, ON (B)(6), 2009. THE (B)(6) DEPT OF PUBLIC HEALTH REPORTED THAT THE PRECOAT SLIDES ARE MORE EASILY BROKEN AFTER SAMPLE PROCESSING AND STAINING. WHEN PLACING SLIDES ON MICROSCOPE STAGE, THE CORNERS AND EDGES OF SLIDES ARE EASILY BROKEN. THE CYTOTECHNOLOGIST WAS HURT IN THE EYE FROM A GLASS SHARD. THE CYTOTECHNOLOGIST USED AN EYE WASH TO WASH THE EYE AND REMOVE THE GLASS PARTICLE. THERE WAS NO INJURY TO EYE AND NO MEDICAL ATTENTION HAS BEEN SOUGHT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SUREPATH PRECOAT SLIDE SUREPATH LIQUID BASED PAP TEST MKQ TRIPATH IMAGING, INC. 090501RA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention