BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HER-2/NEU (4B5) RABBIT MONOCLONAL ANTIBODY

    MDR report key: 2651332 · Received September 25, 2009

    Report

    Report Number
    2028492-2009-00001
    Event Type
    Malfunction
    Date Received
    September 25, 2009
    Date of Event
    August 17, 2009
    Report Date
    August 17, 2009
    Manufacturer
    VENTANA MEDICAL SYSTEMS, INC.
    Product Code
    MVC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER CALLED TO REPORT DISPENSER LOT #680957 OF PATHWAY HER2 (4B5) IS STAINING LIGHTER THAN EXPECTED. NO REPORT OF PT HARM OR PT CARE BEING ADVERSELY AFFECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HER-2/NEU (4B5) RABBIT MONOCLONAL ANTIBODY PATHWAY HER2 (4B5) MVC VENTANA MEDICAL SYSTEMS, INC. 790-2991 680957

    Patients

    Seq Age Sex Outcome Treatment
    1 NA