BEUDAMED
    FDA Adverse Event Other Summary report: N

    RPR CONTROL CARDS 18MM CIRCLE CONTROLS

    MDR report key: 241959 · Received September 23, 1999

    Report

    Report Number
    1119779-1999-00005
    Event Type
    Other
    Date Received
    September 23, 1999
    Date of Event
    August 26, 1999
    Report Date
    August 26, 1999
    Manufacturer
    BECTON DICKINSON
    Product Code
    GMP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    USER REPORTED A POTENTIAL EXPOSURE TO THE CONTROL/ANTIGEN MIXTURE FROM THE RPR CONTROL CARD KIT. DUE TO USER CARELESSNESS, THERE WAS EXPOSURE TO THE EYE OF CONTROL MATERIAL THAT CONTAINS SCREENED HUMAN PLASMA. USER FLUSHED EYE WITH WATER AND WAS EXAMINED BY A DR. USER IS REPORTED TO BE IN GOOD HEALTH. BECAUSE USER IS 6 WEEKS PREGNANT, A FILLING IS BEING MADE AS A PRECAUTION ONLY, EVEN THOUGH NO MALFUNCITON OF THE DEVICE IS INDICATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RPR CONTROL CARDS 18MM CIRCLE CONTROLS ANTISERA, CONTROL FOR NONTREPONEMAL TESTS GMP BECTON DICKINSON NA D903

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN