BEUDAMED
    FDA Adverse Event Other Summary report: N

    VITROS PERFORMANCE VERIFIER II CONTROL

    MDR report key: 629252 · Received August 25, 2005

    Report

    Report Number
    1319808-2005-00207
    Event Type
    Other
    Date Received
    August 25, 2005
    Date of Event
    July 28, 2005
    Report Date
    July 28, 2005
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    JJY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED CLEANING UP AN ACCIDENTAL SPILL OF PERFORMANCE VERIFIER I AND II WITHOUT THE RECOMMENDED PROTECTIVE EQUIPMENT (GLOVES AND EYE PROTECTION). IMPROPER HANDLING OF THE PERFORMANCE VERIFIER CONTROL MATERIAL HAS THE POTENTIAL TO CAUSE THE TRANSMISSION OF DISEASE, AS THERE IS NO COMPLETE ASSURANCE THAT INFECTIOUS AGENTS ARE ABSENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VITROS PERFORMANCE VERIFIER II CONTROL IN VITRO DIAGNOSTIC JJY ORTHO-CLINICAL DIAGNOSTICS NA H5661

    Patients

    Seq Age Sex Outcome Treatment
    1 NA