BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUREPATH PRECOAT SLIDE

    MDR report key: 2125415 · Received June 10, 2011

    Report

    Report Number
    1062336-2011-00004
    Event Type
    Injury
    Date Received
    June 10, 2011
    Date of Event
    April 8, 2011
    Report Date
    June 10, 2011
    Manufacturer
    TRIPATH IMAGING, INC.
    Product Code
    MKQ
    PMA / PMN Number
    P970018
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    AFTER FURTHER INVESTIGATION OF THE COMPLAINT BY QUALITY, NO DOCUMENTATION OF THE INCIDENT COULD BE FOUND AND THE CUSTOMER CONCLUDED THAT THE INCIDENT WAS A MINOR INCIDENT REQUIRING NO MEDICAL INTERVENTION. RELEASE TESTING DATA FROM LOT NUMBER 110225RF WAS REVIEWED AND THE DATA INDICATED THAT ALL TESTING PASSED AND SLIDES MET SPECIFICATIONS. IT IS NORMAL THAT SLIDE EDGES CHIP IN SHIPMENT OR WITH NORMAL HANDLING.

    Description of Event or Problem · 1

    CUSTOMER CALLED TO REPORT THAT LABORATORY TECHNICIANS HAVE BEEN CUT DUE TO CHIPS ON PRE-COAT SLIDES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SUREPATH PRECOAT SLIDE SUREPATH LIQUID BASED PAP TEST MKQ TRIPATH IMAGING, INC. 110225RF

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other