BEUDAMED
    FDA Adverse Event Other Summary report: N

    VITROS CHEMISTRY PRODUCTS PERFORMANCE VERIFIER II

    MDR report key: 559001 · Received December 13, 2004

    Report

    Report Number
    1319808-2004-00328
    Event Type
    Other
    Date Received
    December 13, 2004
    Date of Event
    November 19, 2004
    Report Date
    November 19, 2004
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    JJY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    AN OCD LABORATORY SPECIALIST SPLASHED FLUID IN THEIR EYE WHEN OPENING THE CONTAINER. THE FLUID CONTAINS HUMAN SERUM. THERE WAS NO IMMEDIATE HARM TO THE SUBJECT AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VITROS CHEMISTRY PRODUCTS PERFORMANCE VERIFIER II IN VITRO DIAGNOSTIC CONTROL JJY ORTHO-CLINICAL DIAGNOSTICS NA Q5886

    Patients

    Seq Age Sex Outcome Treatment
    1 NA