BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRESERVCYT

    MDR report key: 2202338 · Received August 9, 2011

    Report

    Report Number
    1222780-2011-00148
    Event Type
    Injury
    Date Received
    August 9, 2011
    Date of Event
    July 12, 2011
    Report Date
    July 12, 2011
    Manufacturer
    HOLOGIC, INC.
    Product Code
    MKQ
    PMA / PMN Number
    P950039
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DR SPLASHED A SMALL AMOUNT OF PRESERVCYT IN HER EYE. THE PRESERVCYT DID CONTAIN PT SAMPLE. HOLOGIC FORWARDED THE MSDS TO THE DR. THE DR INDICATED THAT THERE WAS NO ALLERGIC REACTION. NO FURTHER INFO IS AVAILABLE ON CONDITION OF DR.

    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 Other