BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRESERVCYT SOLUTION

    MDR report key: 2576518 · Received June 21, 2010

    Report

    Report Number
    1222780-2010-00110
    Event Type
    Injury
    Date Received
    June 21, 2010
    Date of Event
    July 1, 2010
    Report Date
    July 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

    ONE YEAR OLD CHILD INGESTED 20 MLS OF PRESERVCYT SOLUTION. MSDS WAS SENT TO THE CUSTOMER. CHILD WAS SEEN BY A DOCTOR. CHILD HAD NEGATIVE LEVEL OF METHANOL. CHILD WAS FINE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 1 YR Other