BEUDAMED
    FDA Adverse Event Other Summary report: N

    SUREPATH PRESERVATIVE FLUID

    MDR report key: 1038871 · Received May 5, 2008

    Report

    Report Number
    1062336-2008-00005
    Event Type
    Other
    Date Received
    May 5, 2008
    Date of Event
    April 16, 2008
    Report Date
    May 5, 2008
    Manufacturer
    TRIPATH IMAGING, INC
    Product Code
    LEA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT WAS AN ACCIDENTAL SPLASH UNRELATED TO THE DESIGN OR FUNCTION OF THE DEVICE. IN ADDITION, THE DEVICE PRODUCT INSERT CONTAINS THE FOLLOWING WARNING, "AVOID SPLASHING OR GENERATING AEROSOLS. OPERATORS SHOULD USE APPROPRIATE HAND, EYE AND CLOTHING PROTECTION." IN THIS EVENT, THE OPERATOR WAS NOT WEARING ANY EYE PROTECTION.

    Description of Event or Problem · 1

    A LAB TECH WAS DISCARDING USED SYRINGING PIPETTES AND STRUCK IN THE EYE WITH A DROPLET OF PRESERVATIVE FLUID FROM A PIPETTE. THE TECH WAS NOT WEARING PROTECTIVE EYEWEAR. THE TECH WAS IMMEDIATELY TREATED WITH EYEWASHES FOLLOWED BY MEDICATIONS AS A PRECAUTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SUREPATH PRESERVATIVE FLUID LIQUID BASED PAP SMEAR COLLECTION LEA TRIPATH IMAGING, INC NOT KNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention