BEUDAMED
    FDA Adverse Event Other Summary report: N

    PRESERVCYT SOLUTION ASSEMBLY (GYN)

    MDR report key: 564420 · Received January 6, 2005

    Report

    Report Number
    1222780-2005-00002
    Event Type
    Other
    Date Received
    January 6, 2005
    Date of Event
    December 16, 2004
    Report Date
    January 6, 2005
    Manufacturer
    CYTYC CORP.
    Product Code
    MKQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    IN 2004, CYTYE'S TECHNICAL SUPPORT DEPARTMENT RECEIVED A CALL FROM A NURSE PRACTITIONER AT THE MEDICAL CENTER REPORTING THAT AS PT WAS TURNING TO DISCARD THE BRUSH/SPATULA COLLECTION DEVICE (CONTAINING A BLOODY GYNECOLOGICAL SAMPLE) PT DRIPPED THE SOLUTION INTO AN OPEN SORE ON THE THUMB OF THEIR LEFT HAND. THE NURSE INDICATED THAT THE SAMPLE HAD BEEN LEFT IN THE PRESERVCYT SOLUTION FOR APPROXIMATELY 2 MINUTES AND ASKED IF THE PRESERVCYT SOLUTION WILL DEACTIVATE HIV. TECHNICAL SUPPORT ADVISED THE CUSTOMER THAT PRESERVCYT SOLUTION CONTAIONS APPROXIMATELY 50% METHANOL AND WILL DEACTIVATE 99.999% OF HIV AFTER 15 MINUTES IN THE SOLUTION. THE NURSE REQUESTED A MATERIAL SAFETY DATA SHEET (MSDS) FOR PRESERVCYT SOLUTION. TECHNICAL SUPPORT FAXED THE MSDS AND THE THINPREP 2000 OPERATOR'S MANUAL TO THE CUSTOMER AS REQUESTED. THE CUSTOMER HAS HAD BASELINE LAB TESTS PERFORMED AND IS TAKING HIV POST-EXPOSURE MEDICATION.

    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 58 YR Other