BEUDAMED
    FDA Adverse Event Injury Summary report: N

    APTIMA HPV-GT

    MDR report key: 5432124 · Received February 11, 2016

    Report

    Report Number
    2024800-2016-00001
    Event Type
    Injury
    Date Received
    February 11, 2016
    Date of Event
    January 15, 2016
    Report Date
    February 11, 2016
    Manufacturer
    HOLOGIC INCORPORATED
    Product Code
    OYB
    PMA / PMN Number
    P120007
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    AN INCIDENT OCCURRED AT (B)(6) WHEN A CUSTOMER HAD A SMALL AMOUNT OF (B)(6) ENZYME SPLASH INTO HIS EYE AS THE REAGENT WAS BEING DISCARDED AFTER USE. THE OPERATOR WAS WEARING PRESCRIPTION GLASSES AT THE TIME OF THE INCIDENT, BUT A SPLATTER GOT UNDER HIS GLASSES AND INTO HIS EYE. NO REAGENT SPLASHED ONTO THE CUSTOMER'S SKIN. THE CUSTOMER IMMEDIATELY RINSED THEIR EYES WITH PLENTY OF WATER. THE OPERATOR'S INDICATED THERE WAS A LITTLE STING, BUT HIS EYES WERE NOT WATERING. WHEN FOLLOWING UP WITH THE CUSTOMER, HE DID NOT SEEK MEDICAL ATTENTION AND HIS EYES ARE FEELING FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    88595 APTIMA HPV-GT IN-VITRO DIAGNOSTIC ASSAY OYB HOLOGIC INCORPORATED

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention