BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRESERVCYT SOLUTION

    MDR report key: 1742969 · Received June 29, 2010

    Report

    Report Number
    1222780-2010-00104
    Event Type
    Injury
    Date Received
    June 29, 2010
    Date of Event
    June 1, 2010
    Report Date
    June 1, 2010
    Manufacturer
    HOLOGIC INC.
    Product Code
    MKQ
    PMA / PMN Number
    P950039
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PREGNANT WOMAN SPILLED PRESERVCYT SOLUTION ON HER HAND. SHE WASHED HER HAND WITH SOAP AND WATER. HOLOGIC FAXED THE MSDS SHEET TO THE CUSTOMER. SHE STATED THAT SHE IS FINE.

    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 Other