BEUDAMED
    FDA Adverse Event Other Summary report: N

    PRESERV CYT SOLUTION VIAL ASSEMBLY (GYN)

    MDR report key: 388786 · Received April 12, 2002

    Report

    Report Number
    1222780-2002-00001
    Event Type
    Other
    Date Received
    April 12, 2002
    Date of Event
    March 15, 2002
    Report Date
    April 11, 2002
    Manufacturer
    CYTYC CORPORATION
    Product Code
    LEA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IN 2002, A SECRETARY FOR DR REPORTED AN INCIDENT TO CYTYC'S TECHNICAL SUPORT (TS) DEPARTMENT THAT WAS REPORTED TO HER BY AN OFFICE MGR AT A FACILITY. REPORTER CLAIMED THAT OFFICE MGR HAD CALLED AND REPORTED AN INCIDENT WHERE PRESERVCYT SOLUTION CONTAINING A PT'S CERVICAL SAMPLE HAD BEEN ACCIDENTALLY SPLASHED INTO AN EMPLOYEE'S EYES AT THEIR FACILITY. THE EMPLOYEE INVOLVED WHOSE NAME IS UNKNOWN AT THIS TIME IS A MEDICAL ASSISTANT WORKING IN THE CYTOLOGY DEPARTMENT FOR THE MEDICAL OFFICE. TS CONTACTED THE OFFICE MGR EXPLAINED THAT THE EMPLOYEE HAD RINSED THEIR EYES FOR 15 TO 25 MINUTES AS SUGGESTED IN THE MATERIAL SAFETY DATA SHEET (MSDS) FOR PRESERVCYT SOLUTION. OFFICE MGR HAD THE EMPLOYEE GO TO THE ER DUE TO MINOR EYE IRRITATION. AFTER FURTHER RINSING OF THE EYE THE ER DOCTOR DETERMINE THAT NO FURTHER MEDCIAL ATTENTION WOULD BE REQUIRED. OFFICE MGR ALSO INFORMED TS THAT THE MEDICAL ASSISTANT HAS NOT EXPERIENCED ANY LINGERING ADVERSE EFFECT AS A RESULT OF THIS INCIDENT. THERE HAVE BEEN NO FURTHER REPORTS REGARDING THE INCIDENT RECEIVED BY CYTYC IN THE 24 SINCE TS LAST SPOKE WITH THE OFFICE MGR. IF CYTYC OBTAINS ADD'L INFO IT WILL BE FORWARDED TO THE FDA VIA A SUPPLEMENTAL REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRESERV CYT SOLUTION VIAL ASSEMBLY (GYN) REAGENT FOR CYTOLOGY SLIDE PREPERATION LEA CYTYC CORPORATION * *

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO Other| R