BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    URICULT

    MDR report key: 18274 · Received December 8, 1994

    Report

    Report Number
    MW1004349
    Event Type
    Malfunction
    Date Received
    December 8, 1994
    Date of Event
    November 9, 1994
    Report Date
    November 22, 1994
    Manufacturer
    ORION DIAGNOSTICA, INC.
    Product Code
    JSC
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    AR, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    WHEN THE DEVICE IS RECEIVED FROM THE DISTRIBUTOR THERE IS MOISTURE IN THE CONTAINERS AND MELTING OF THE MEDIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 URICULT BACTERIA DETECTION JSC ORION DIAGNOSTICA, INC. UH024

    Patients

    Seq Age Sex Outcome Treatment
    1 *