BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRESERVCYT SOLUTION

    MDR report key: 1661450 · Received April 15, 2010

    Report

    Report Number
    1222780-2010-00059
    Event Type
    Injury
    Date Received
    April 15, 2010
    Date of Event
    April 1, 2010
    Report Date
    April 1, 2010
    Manufacturer
    HOLOGIC, INC
    Product Code
    MKQ
    PMA / PMN Number
    P950039
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    MEDICAL ASSISTANT SPILLED PRESERVCYT SOLUTION WHICH CONTAINED PT SAMPLE ON HER AND A CO-WORKER'S (PRACTICE ADMINISTRATOR) HANDS. THE MEDICAL ASSISTANT WAS PLACING THE VIAL IN A PLASTIC BAG WHEN IT SPILLED. THE CAP WAS NOT SCREWED ON APPROPRIATELY. THE SAMPLE HAD BEEN IN THE SOLUTION FOR APPROX 2 HOURS. THE SAMPLE WAS FROM A PT WHO POSSIBLY HAS (B) (6). CUSTOMER HAD AN MSDS FOR PRESERVCYT ON HAND. BOTH THE MEDICAL ASSISTANT AND THE PRACTICE ADMINISTRATOR WASHED THEIR HANDS WITH ANTI-BACTERIAL SOAP AND WATER. HOLOGIC HAS MADE MULTIPLE ATTEMPTS AT OBTAINING MORE INFO REGARDING THE HEALTH OF THE MEDICAL ASSISTANT AND PRACTICE ADMINISTRATOR, BUT CALLS HAVE NOT BEEN RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRESERVCYT SOLUTION PRESERVATIVE, CYTOLOGICAL MKQ HOLOGIC, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Other