BEUDAMED
    FDA Adverse Event Other Summary report: N

    PRESERVCYT SOLUTION ASSEMBLY (GYN)

    MDR report key: 625958 · Received July 6, 2005

    Report

    Report Number
    95623-2005-00005
    Event Type
    Other
    Date Received
    July 6, 2005
    Date of Event
    June 22, 2005
    Report Date
    July 6, 2005
    Manufacturer
    CYTYC CORP.
    Product Code
    MKQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    IN 2005, CYTYC'S TECHNICAL SUPPORT (TS) DEPARTMENT RECEIVED A CALL FROM AN EMPLOYEE IN DR'S OFFICE WHO REPORTED THAT THE DR'S MEDICAL ASSISTANT HAD PRESERVCYT SOLUTION ACCIDENTALLY SPLASHED ONTO THEIR FACE. MEDICAL ASSISTANT WSAS HOLDING THE PRESERVCYT SOLUTION VIAL WHILE THE DR COLLECTED THE PT'S CERVICAL SAMPLE. FLUID FROM THE VIAL WAS PLASHED ONTO THEIR FACE WHILE THE DR WAS RINSING THE COLLECTION DEVICE IN THE VIAL. MEDICAL ASSISTANT RINSED THEIR FACE WTIH WATER. THE CALLER REQUESTED A MATERIAL SAFETY DATA SHEET (MSDS) FOR PRESERVCYT SOLUTION, WHICH WAS FAXED TO THE CALLER BY THE TS REPRESENTATIVE. DURING A FOLLOW-UP CONVERSATION, WHO INFORMED THE TS REPRESENTATIVE THAT MEDICAL ASSISTANT HAD EXPERIENCED NO ADVERSE REACTIONS AND HAD NOT SCHEDULED ANY DIAGNOSTIC TESTING OR ADDITIONAL MEDICAL TREATMENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO Other