BEUDAMED
    FDA Adverse Event Other Summary report: N

    PRESERVCYT SOLUTION

    MDR report key: 3131145 · Received May 23, 2013

    Report

    Report Number
    1222780-2013-00098
    Event Type
    Other
    Date Received
    May 23, 2013
    Date of Event
    April 1, 2013
    Report Date
    April 26, 2013
    Manufacturer
    HOLOGIC INC
    Product Code
    MKQ
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    TWO MIDWIVES REPORTED HAVING AN ALLERGIC REACTION TO PRESERVCYT. THE TWO WOMEN COMPLAINT ABOUT IRRITATION AROUND THE MOUTH. THIS CURRENTLY IS AN ONGOING INVESTIGATION THAT HOLOGIC IS FOLLOWING UP ON. A SUPPLEMENTAL REPORT WILL BE SENT WHEN MORE INFORMATION IS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    228333 PRESERVCYT SOLUTION PRESERVATIVE, CYTOLOGICAL MKQ HOLOGIC INC

    Patients

    Seq Age Sex Outcome Treatment
    1 Other