BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYTOLYT SOLUTION

    MDR report key: 4944954 · Received July 24, 2015

    Report

    Report Number
    1222780-2015-00131
    Event Type
    Injury
    Date Received
    July 24, 2015
    Date of Event
    January 1, 2015
    Report Date
    July 24, 2015
    Manufacturer
    HOLOGIC INC.
    Product Code
    MKQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    A NURSE FROM THE (B)(6) REPORTED A (B)(6) (BOY) INGESTED HALF OF A VIAL CYTOLYT SOLUTION. HOLOGIC'S TECHNICAL SERVICE PERSONNEL PROVIDED THE NURSE WITH THE CONCENTRATION OF METHANOL IN VIAL. NURSE REPORTED THAT THE CHILD IS BEING TREATED AT A HOSPITAL AND THAT THE INCIDENT TOOK PLACE AT A DR'S OFFICE. HOLOGIC'S TECHNICAL SERVICE PERSONNEL FOLLOWED UP WITH NURSE. THE CHILD WAS GIVEN A BLOCKING AGENT AND CHECKED FOR METHANOL LEVEL. METHANOL LEVEL PROVED TO BE NEGATIVE AND THE CHILD WAS DISCHARGED FROM HOSPITAL. THIS IS A REPORTABLE EVENT IN THE UNITED STATES SINCE INGESTING CYTOLYT SOLUTION COULD RESULT IN A POTENTIALLY SERIOUS INJURY OR ILLNESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    483422 CYTOLYT SOLUTION CYTOLYT MKQ HOLOGIC INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 2 YR Hospitalization