BEUDAMED
    FDA Adverse Event Other Summary report: N

    CYTOLYT SOLUTION CENTRIFUGE TUBE (30ML)

    MDR report key: 318172 · Received February 27, 2001

    Report

    Report Number
    1222780-2001-00002
    Event Type
    Other
    Date Received
    February 27, 2001
    Date of Event
    February 5, 2001
    Report Date
    February 27, 2001
    Manufacturer
    CYTYC CORP.
    Product Code
    IFB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD, US
    Reporter Occupation
    NO INFORMATION

    Narratives

    Description of Event or Problem · 1

    IN 2001 REPORTER CALLED CYTYC'S TECHNICAL SERVICE DEPT TO REPORT THAT ONE OF HIS STAFF MEMBERS ACCIDENTALLY SPLASHED CYTOLYT SOLUTION INTO THEIR EYES. THE INCIDENT OCCURRED WHEN THE EMPLOYEE WAS SNAPPING THE LID OF THE CONTAINER CLOSED AND A SMALL AMOUNT OF CYTOLYT SOLUTION CONTAINING A SPUTUM SAMPLE SPLASHED INTO THEIR EYES. REPORTER HAD THE EMPLOYEE FLUSH THEIR EYES WITH WATER FOR 15 MINUTES ACCORDING TO THE INSTRUCTIONS IN THE MATERIAL SAFETY DATA SHEET (MSDS). HE ALSO STATED THAT AFTER FLUSHING THEIR EYES WITH WATER THE EMPLOYEE DID NOT EXPERIENCE ANY PAIN OR OTHER SYMPTOMS, BUT THAT THE EMPLOYEE WAS REFERRED TO THEIR EMPLOYEE HEALTH DEPT AS A PRECAUTION. DURING A FOLLOW-UP PHONE CALL TO THE CUSTOMER IN 2/01 REPORTER REITERATED THAT THE EMPLOYEE DID NOT SPLASH VERY MUCH SOLUTION INTO THEIR EYES AND THAT THEIR EYES WERE IMMEDIATELY FLUSHED WITH WATER AFTER THE INCIDENT. THE EMPLOYEE WENT TO AN OPTOMETRIST WHO DETERMINED THAT NO FURTHER MEDICAL ATTENTION WAS REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    7888 CYTOLYT SOLUTION CENTRIFUGE TUBE (30ML) TRANSPORT MEDIUM FOR CYTOLOGIC SAMPLES IFB CYTYC CORP. 0200012 NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO Other| R