BEUDAMED
    FDA Adverse Event Other Summary report: N

    PRESERVCYT SOLUTION VIAL ASSEMBLY (GYN)

    MDR report key: 317493 · Received February 26, 2001

    Report

    Report Number
    1222780-2001-00001
    Event Type
    Other
    Date Received
    February 26, 2001
    Date of Event
    January 30, 2001
    Report Date
    February 20, 2001
    Manufacturer
    CYTYC CORPORATION
    Product Code
    MKQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IN 1/01, THE SAFETY OFFICER CALLED CYTYC'S TECHNICAL SERVICE SERVICE (TS) DEPARTMENT TO REPORT THAT AN EMPLOYEE HAD ACCIDENTALLY SPLASHED PRESERVCYT SOLUTION INTO THEIR EYES. THE INCIDENT OCCURRED WHEN THE EMPLOYEE WENT TO PICK UP THE VIAL BY THE CAP, WHICH HAD NOT BEEN PROPERLY TIGHTENED. THE SAFETY OFFICER HAS SINCE BEEN CONTACTED AND WAS UNABLE TO CONFIRM WHETHER OR NOT THERE WAS A PT SAMPLE IN THE VIAL AT THE TIME. THE SAFETY OFFICER DID CONFIRM THAT THE EMPLOYEE RECEIVED IMMEDIATE FIRST AID, WHICH INVOLVED FLUSHING THEIR EYES WITH COPIOUS AMOUNTS OF WATER. THE SAFETY OFFICER REQUESTED A COPY OF THE MATERIAL SAFETY DATA SHEET (MSDS) FOR PRESERVCYT SOLUTION, WHICH TS FAXED TO THE SAFETY OFFICER. A FOLLOW-UP CALL WAS MADE BY TS ON 2/16/01, AT WHICH TIME THE SAFETY OFFICER INDICATED THAT THE EMPLOYEE REQUIRED NO FURTHER MEDICAL ATTENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    7683 PRESERVCYT SOLUTION VIAL ASSEMBLY (GYN) REAGENT FOR CYTOLOGY SLIDE PREPARATION MKQ CYTYC CORPORATION 70097-001 NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO Other| R