BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRESERVCYT

    MDR report key: 1944487 · Received December 23, 2010

    Report

    Report Number
    1222780-2010-00213
    Event Type
    Injury
    Date Received
    December 23, 2010
    Date of Event
    December 8, 2010
    Report Date
    December 20, 2010
    Manufacturer
    HOLOGIC, INC.
    Product Code
    MKQ
    PMA / PMN Number
    P950039
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A (B)(6) CHILD ACCOMPANIED HIS/HER MOTHER TO HER DOCTOR FOR HER CERVICAL SCREENING TEST. AT SOME TIME DURING THE APPOINTMENT THE CHILD INGESTED THE PRESERVCYT FROM THE VIAL. THE CHILD WAS SEEN AT THE HOSPITAL.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 2 YR Other