BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRESERVCYT SOLUTION

    MDR report key: 1663424 · Received April 16, 2010

    Report

    Report Number
    1222780-2010-00060
    Event Type
    Injury
    Date Received
    April 16, 2010
    Date of Event
    March 30, 2010
    Report Date
    March 30, 2010
    Manufacturer
    HOLOGIC, INC.
    Product Code
    MKQ
    PMA / PMN Number
    P950039
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A (B) (6) (B) (6) MALE CHILD, WHILE AT THE DOCTOR'S OFFICE, PLACED HIS RIGHT HAND INSIDE OF A VIAL OF PRESERVCYT SOLUTION AND SWIRLED IT AROUND. THE MSDS FOR PRESERVCYT WAS FAXED TO THE CUSTOMER. THE CHILD DID NOT DISPLAY ANY ADVERSE EFFECTS AND DID NOT REQUIRE FURTHER MEDICAL ATTENTION.

    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 2 YR Other