BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CULTURETTE, S/P BRAND

    MDR report key: 14608 · Received March 17, 1994

    Report

    Report Number
    14608
    Event Type
    Malfunction
    Date Received
    March 17, 1994
    Date of Event
    March 10, 1994
    Report Date
    March 17, 1994
    Manufacturer
    BAXTER DIAGNOSTICS, INC.
    Product Code
    JSC
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    OH, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PACKED COTTON AT THE BOTTOM OF THE CULTURETTE CAME OUT OF THE CULTURETTE WITH COTTON SWAB AND WAS SWALLOWED BY TWO PTS, AND RECOVERED FROM THE THROAT OF A THIRD PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CULTURETTE, S/P BRAND CULTURETTE JSC BAXTER DIAGNOSTICS, INC. 310051

    Patients

    Seq Age Sex Outcome Treatment
    1 *